Clinical Trials
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Immunology
A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis
Apr 2013This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis
Apr 2013This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
Apr 2013The aim of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression. (FEC-TH)
Apr 2013The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.
Apr 2013The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs
Mar 2013The main objectives are to evaluate the efficacy of VX 509 across a range of doses and to evaluate the early effect of VX 509 administration on joint structures as assessed by magnetic resonance imaging (MRI)
NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years
Mar 2013The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
Cologne Cohort of Neutropenic Patients (CoCoNut)
Mar 2013The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia (LAMVIRE)
Mar 2013Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Mar 2013The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant.
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
Mar 2013This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics. The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.
Effect of Andosan in Patients With Rheumatoid Arthritis (Andosan-RA)
Mar 2013Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Although the etiology of RA is unknown, it is generally accepted that it arises from an interplay of genetic predisposition (in particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g. autoantibody production), and environmental factors. The prevalence and incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most important is premature cardiovascular disease that significantly contributes to increased mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids, traditional disease modifying antirheumatic drugs (including methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint replacement surgery and in need of rehabilitation. However, the treatment opportunities are still not optimal. In a large proportion of the patients, full control of the disease is not possible due to limited effect of available therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new therapeutic alternatives to treat RA. Since studies on healthy volunteers and IBD-patients support that the mushroom extract AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a pilot study whether this effect also was evident in patients with RA. A potential anti-inflammatory effect could prove beneficial in these seriously ill patients, who accordingly could experience less side effects (edema, granulocytopenia, diminished tissue repair) due to potential reduction number and dose of disease modifying drugs.
Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
Mar 2013This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
Mar 2013Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients. Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.
Autologous Adipose Tissue Derived Mesenchymal Progenitor Cells Therapy for Patients With Knee Osteoarthritis
Mar 2013Three injections each of 3 ml autologous adipose tissue derived progenitor cells, time-points for intervention: 1) initial injection; 2) 1 months following initial injection and 3) 3 months following initial injection. This result in a total treatment duration of 3 months.
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure (DESYRE)
Mar 2013This study is designed to assess the following hypothesis: "early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event)".
Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation (REP0211)
Mar 2013The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D) patients.
The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
Mar 2013In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE. The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults. Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?
Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium (ParoPAR)
Mar 2013Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial. These new biotherapies could have an impact on periodontal status - either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis, - or a positive modulation of the host response by inhibiting bone resorption of the alveolar process. To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Mar 2013The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Mar 2013The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
Feb 2013To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients ≥ 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Khoala)
Feb 2013Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).
Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)
Feb 2013Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
CE-US in Renal Transplantation
Feb 2013Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction. Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy (NEURISK)
Feb 2013The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis
Feb 2013This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands.
Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults
Feb 2013This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.
Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis
Feb 2013This study is the radiological component of an earlier registered RCT under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Feb 2013The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip
MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.
Feb 2013To describe the safety profile of mepolizumab in subjects receiving long-term treatment
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)
Feb 2013The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
Feb 2013This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Feb 2013The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (TOMMY)
Feb 2013In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.
Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis
Feb 2013The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in the patients with carpometacarpal(CMC) osteoarthritis who are scheduled for surgery in the CMC-joint. Our study hypothesis is that compared to participants in the intervention group, significantly more participants in the control group have received CMC-surgery after two years.
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
Feb 2013The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire
Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease
Feb 2013To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease
Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)
Feb 2013Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
Changes of cytokines and regulatory T cells in renal transplant recipients after switch to the mTOR inhibitor Everolimus. A Single center trial, non-blinded, non-randomized.
Feb 2013Changes of cytokines in renal transplant recipients after switch of immunosuppression from CNI (calcineurin inhibitor) to the mTORi (mTOR inhibitor) Certican.
ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis
Feb 2013This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with DMARDs will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
Feb 2013To assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed or refractory NHL who have received at least one prior therapy containing rituximab as one of the treatments.
DRV/r + RPV QD: Efficacy and Toxicity Reduction
Feb 2013Clinical approach to HIV infection treatment is based on the use of highly active antiretroviral therapies (HAART) and recent national and international guidelines for guiding HIV therapy recommend the use of triple-combination therapy using antiretrovirals with 2 nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a boosted protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase inhibitor (II). In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term side effects, as for example the impact on renal function, remain principal problem. In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk condition [1,2]. Efficacy of HAART, with increase of media survival and the parallel decrease of mortality, has underlined the necessity to reflect on long term HAART effects [3]. There are many evidences of HAART-related toxicity that, in spite of the necessity of a life-saving therapy, focus on the additional costs of this situation, in terms of health as well as in terms of economic costs. Particular attention has been focused on the impact of some drugs on renal function, as tenofovir, especially on tubule, without forgetting the modification of lipid and bone metabolisms. According to further studies which have evidenced the potential of some recently introduced molecules [4,5], the investigators had the need to realize a study to deepen the feasibility of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent NRTIs-related long-term toxicity. The investigators have designed a prospective randomized controlled trial, open-label, with a duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia from at least 3 months. In fact, there are a few data about association of these drugs, which it has been shown to be safe, well tolerated, and with a strong pharmacological synergy, without nucleos(t)idic backbone, while the necessity to minimize the costs toxicity-related is becoming increasingly compelling. According to clinical experience and literature data, the investigators hope this study shows positive results in term of immune-virological efficacy, as well as in term of decrease of VACS index - a complex parameter which has the purpose to quantify general organic decay - and markers of lipid and bone metabolism, in group which receives dual-therapy versus the group with standard therapy. These results could stimulate further studies on less aggressive and however effective therapeutic regimens, with more sustainable biological and economic costs.
Acid-suppressing Drugs Pregnancy Asthma Offspring Study
Feb 2013The purpose of this study is - To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood. - To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.
Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Feb 2013The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.
The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant recipients: a randomized double blinded placebo controlled intervention study.
Feb 2013To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n-3 polyunsatturated fatty acids compared to placebo.
Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital. (ALL)
Feb 2013This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia (AML)
Feb 2013The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.
Feb 2013The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).
Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas (LeMLAR)
Feb 2013Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)
Feb 2013The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy, costs and safety.
Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant Recipients
Jan 2013The purpose of this study is to assess the pharmacokinetics (PK) efficacy and safety of Belatacept in stable pediatric renal transplant recipients.
A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Jan 2013A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis. There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184.
Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients
Jan 2013The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Antibiotics and Hydroxychloroquine in Crohn's
Jan 2013There is growing evidence that Crohn's disease may be caused by replication of bacteria, perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell). Laboratory studies show that a combination of antibiotics that can penetrate macrophages (such as ciprofloxacin and doxycycline) together with the anti-malarial drug hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps them to kill intracellular bacteria) is particularly effective at killing the E. coli within macrophages.
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Jan 2013This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2, 3, and 4 HCV-infection who are co-infected with HIV-1. A total of 220 HCV subjects who are co-infected with HIV-1 will be enrolled into a single arm and treated with oral SOF 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include HCV genotype 1, 2, 3, and 4 HCV treatment naive subjects (including IFN ineligible) and HCV genotype 2 and 3 HCV treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate (SERUM)
Jan 2013The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTFreedom)
Jan 2013The main purpose of the study is to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
Jan 2013The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group.
Jan 2013The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification in case of a positive FDG-PET/CT after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen.
Application of FSME-Immun® and Epaxal® in allergic patients
Jan 2013To assess the humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster
Emollients in the Management of Atopic Dermatitis
Jan 2013The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
The Effect of Antacids and Multivitamins on Raltegravir
Jan 2013This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
Jan 2013Whole body MRI with diffusion weighted imaging is a useful imaging tool - staging and diagnosis - therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
Jan 2013The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
Jan 2013This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184.
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis (TRANSFIGURE)
Jan 2013To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)
Jan 2013To demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess long term efficacy, safety and tolerability of secukinumab.
Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2) (Nilo Post-STIM)
Jan 2013The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.
Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy
Jan 2013Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).
Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle
Jan 2013The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.
Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)
Jan 2013To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function
A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Jan 2013This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly (for patients entering from WA22762) or every two weeks (for patients entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Jan 2013The main objective is to investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
Jan 2013The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.
A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists
Jan 2013To assess, in the same study, the safety of sarilumab and tocilizumab in patients with rheumatoid arthritis (RA) who are inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
Control and Burden of Asthma and Rhinitis (ICAR)
Jan 2013An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)
A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse
Jan 2013The objective of this study is to explore the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on PFS
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Jan 2013This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.
Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee
Jan 2013The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home (OCTAGEN)
Jan 2013To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS) controller treatment guided by exhaled NO measurement made at home with usual care asthma management with regard to asthma control (primary outcome), asthma-related quality of life, lung function, airway inflammation, medication use, and asthma events. To understand changes in patient behaviour triggered by daily FENO measurement at home, for example treatment adherence and voluntary allergen exposure.
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Jan 2013This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
Jan 2013To evaluate the efficacy of MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn’s Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn’s disease.
Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation
Jan 2013The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described. Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.
A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease
Jan 2013To compare the effect on disease activity of a single i.v. dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn’s disease
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)
Jan 2013The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID.
Jan 2013To assess the optimal duration of consolidation treatment with nilotinib 300 mg BID in order that patients remain in treatment free remission (≥MR4.0) without molecular relapse 12 months after cessation of nilotinib.
A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab
Jan 2013The study objective is to assess the long-term safety, tolerability, efficacy, and the immunogenicity of the 100 mg/mL adalimumab formulation.
Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?
Jan 2013Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly.
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Jan 2013This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.
Jan 2013To evaluate the risk of serious asthma related events during treatment with Symbicort pMDI or budesonide pMDI alone (asthma-related deaths, intubations, hospitalizations).
Roflumilast Plus Montelukast in Adults With Severe Asthma
Jan 2013The purpose of this study is to evaluate the effect of roflumilast alone and in combination with montelukast on forced expiratory volume in 1 second (FEV1) in patients with inadequately controlled asthma.
Phase III Study of CG100649 in Osteoarthritis Patients
Jan 20136-week Efficacy Study The objective of this study is to prove the safety and non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The primary efficacy parameter is the difference from Baseline to Week 6 in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale. Extended Safety Study The objective of the Extended Safety Study is to collect a total of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data, and an additional 18 weeks of safety data for those subjects who agree on the consent form to continue into the Extended Safety Study. Subjects will be administered CG100649 2 mg only during 18 weeks of Extended Safety Study.
Evaluation of Intra-articular Injection of Autologous Protein Solution ("CertuSyn") for the Treatment of Osteoarthritis (OA)
Jan 2013This prospective single-center study will evaluate the safety and tolerability of a single dose of "CertuSyn" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assesing patient pain and functionality.
A prospective, single-centre, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the response to skin directed treatment with Ustekinumab
Jan 2013Do the imaging features of subclinical enthesopathy (the earliest change seen in psoriatic arthritis), as measured by peripheral joint ultrasound (USS) and whole body MRI, in patients with moderate-to-severe psoriasis (PASI>10), change when treated for 24 weeks with ustekinumab (at standard dose) for their psoriatic skin disease?
SST0001 in Advanced Multiple Myeloma
Jan 2013Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated with cancer metastasis, angiogenesis, and inflammation. The heparanase enzyme is a promising target for development of new anticancer drugs. HS and the structurally related heparin are present in most animal species. As an analogue of the natural substrate of heparanase HS, heparin is considered to be a potent inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity and are strictly related to the anti-heparanase activity. In preclinical murine models SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models, with a significant reduction of subcutaneous growth of different multiple myeloma cell lines, when SST0001 was administered either alone or in combination with dexamethasone. The purpose of this study is to determine the safety and tolerability of escalating doses of SST0001 in the treatment of advanced refractory multiple myeloma.
A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients
Jan 2013To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors (NexT)
Jan 2013This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.
Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers
Jan 2013HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed in hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR) signaling cascades and is an essential mediator not only in B-cell dependent but also in myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel therapeutic agent for the treatment of autoimmune diseases such as RA. In view of the above, further development of HM71224 for the treatment of RA is warranted. In this first-in-man (FIM) study, a single and multiple dose escalation design will be employed, in which the primary objective is to evaluate the safety and tolerability of the compound. The biomarkers included as pharmacodynamic (PD) variables are chosen as they are indicators for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and pERK).
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)
Jan 2013The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Jan 2013To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Jan 2013The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs
Dec 2012Determine whether baricitinib monotherapy is noninferior to MTX monotherapy in the treatment of patients with moderate to severe active RA who have had limited or no treatment with MTX and are naive to other conventional or biologic DMARDs, as assessed by the proportion of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24.
A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission
Dec 2012The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age >= 55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy
A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
Dec 2012To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D) of BEZ235 when administered twice daily (BID) as a single agent in patients with relapsed or refractory acute leukemia To determine the dose-limiting toxicity (DLT)
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
Dec 2012To evaluate the efficacy of brodalumab compared with placebo as measured by the change in asthma control (based on the Asthma Control Questionnaire [ACQ]) from baseline at week 24 in subjects with inadequately controlled asthma and high reversibility despite standard of care.
A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)
Dec 2012The main aim of this project is to test the hypothesis that the presence or absence of specific synovial cellular and molecular signatures(B cells and B cell-associated signatures), assessed following a synovial tissue biopsy, will enrich for response / non-response to the B cell depleting anti-CD20 monoclonal antibody (mAb) Rituximab. The primary aim of this project is to show that in patients failing anti-TNF therapy, with a B cell poor synovial pathotype, Rituximab is inferior to Tocilizumab therapy.
An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA)
Dec 2012Part I: To evaluate the long-term safety and tolerability of canakinumab and to assess the retention rate of canakinumab treated patients Part II: To assess the long-term safety and tolerability of canakinumab
A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.
Dec 2012Determine the 3-year graft failure rate in patients testing positive for HLA Ab at baseline or within 3 years of randomization who receive an optimized anti-rejection medication intervention with prednisone, Tac and MMF (‘treatment’), compared to a control group who test positive for HLA Ab at baseline or within 3 years post-randomization who remain on their established immunotherapy and whose clinicians are not aware of their Ab status.
Rituximab in Systemic Sclerosis (RECOVER)
Dec 2012The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis
Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial
Dec 2012To compare once daily dosing to twice daily dosing
A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
Dec 2012To assess the tumor response rate (defined according to the IMWG uniform response criteria)
A Phase II Trial of combination treatment with Vorinostat, Bortezomib and Dexamethasone in participants with Relapsed Multiple Myeloma
Dec 2012To assess the overall response rate (partial response or better) of patients with relapsed multiple myeloma, after combination treatment with vorinostat, bortezomib and dexamethasone.
Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression
Dec 2012To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B])
Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis. (SPECIES)
Dec 2012The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma
Dec 2012This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second (FEV1). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with monteulkast over 12 weeks.
A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib
Dec 2012The purpose of this study is to determine the rate of successful treatment-free remission (TFR) within the first 12 months following cessation of treatment in patients who achieved and maintained a molecular response (MR) 4.5 on nilotinib after a switch from imatinib. TFR phase is often referred to as discontinuation phase in other studies.
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts? (ProNut)
Dec 2012The aim of this study is to identify, based on standardized food provocation tests, which nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of other food allergies or a history of a severe previous reaction
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Nov 2012The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
Nov 2012To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).
Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients
Nov 2012This study aims to assess the effects of early insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.
Emollients in the management of atopic dermatitis in children: prevention of flares.
Nov 2012To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.
A single center, randomized parallel group pilot study to investigate the mechanism of action of tapentadol PR and oxycodone CR in subjects with osteoarthritis knee pain
Nov 2012To assess which pain mechanisms (with specific focus on the descending inhibition) are modulated by daily administration of 2 x 100-250 mg tapentadol PR compared to 2 x 20-50 mg oxycodone CR in subjects with osteoarthritic (OA) knee pain during a treatment period of 4-weeks (preceded to a titration period of up to 15 days).
A multicentre, randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout.
Nov 2012The primary study objective is to determine whether Febuxostat 80 mg, given once a day, is better than Allopurinol 300 mg/die considering the proportion of subjects, at visit 1 (week 4), whose serum urate concentrations will be below 6 mg/dL (357 µmol/L).
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis
Nov 2012Determine whether baricitinib 4 mg QD is superior to placebo in the treatment of patients with moderately to severely active RA who have had inadequate response to or are intolerant to at least 1 cDMARD (cDMARD-IR [inadequate response] patients) and who have not received a biologic DMARD, as assessed by the proportion of patients achieving ACR20 at Week 12.
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Nov 2012Modified progression free survival (mPFS) per independent review facility (IRF)
A Study of Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)
Nov 2012This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose frequency in patients with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing. Patients will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 4 consecutive infusions, patients who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.
A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-α Antagonists
Nov 2012To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: • reduction of signs and symptoms at week 24 and • improvement of physical function over 24 weeks in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists
Prevalence of Food Allergies to Proteins From Different Legumes
Nov 2012The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.
Multicenter, open-label, non-randomized Phase II trial of dasatinib in patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) who meet criteria for late suboptimal response after prior imatinib treatment.
Nov 2012To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
An open label, randomized (2:1) Phase 2b study of Dasatinib vs. Imatinib in patients with Chronic Phase Chronic Myeloid Leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg Imatinib
Nov 2012To compare the rate of major molecular response (MMR) at 12 months after Day 1initiation of first line treatment with imatinib, in patients randomized at month 3 to treatment with dasatinib 100mg QD or imatinib at any dose, after less than optimal response to 1st line imatinib
A multi-centre, randomised, double-blind, placebo-controlled, dose ranging study to evaluate the safety and efficacy of GSK2586184 in patients with chronic plaque psoriasis
Nov 2012To estimate the relationship between dose of GSK2586184 and clinical response as assessed by PASI score after 12 weeks of treatment in patients with moderate to severe plaque-type psoriasis.
In-vivo biological standardization of Dermatophagoides, Betulaceae and Graminaceae extracts for the determination of the biological activity in HEP units
Oct 2012Determination of the biological activity of allergenic extracts of Dermatophagoides, Betulaceae and Graminaceae in HEP units (histamine equivalent prick) in order to define an in-house reference preparation (IHRP).
Alemtuzumab and rheumatoid arthritis - an immunisation study
Oct 2012To compare the ability to mount immune responses (to measure the function of the immune system) in patients who received alemtuzumab for rheumatoid arthritis between 1991 and 1994 and a matched control group with long-standing rheumatoid arthritis. The control group will be matched for disease duration (within 5 years of matched case), age (within 10 years of matched case) and gender.
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579 AM3)
Oct 2012The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)
Oct 2012The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.
A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation
Oct 2012To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline
A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women
Oct 2012To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
An adaptive, placebo-controlled, Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus.
Oct 2012• To estimate the relationship between dose of GSK2586184 and pharmacodynamic effect on expression of selected messenger ribonucleic acid (mRNA) transcripts following 2 weeks of treatment in SLE patients • To estimate the relationship between dose of GSK2586184 and clinical response as assessed by SELENA SLEDAI score following 12 weeks of treatment in SLE patients • To evaluate the safety and tolerability of repeat doses of GSK2586184 in SLE patients.
A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant
Oct 2012To evaluate the efficacy (as measured by overall survival) of pixantrone plus rituximab compared to gemcitabine plus rituximab in patients with a diagnosis of de novo DLBCL, DLBCL transformed from indolent lymphoma, or follicular grade 3 lymphoma who have relapsed after at least 1 prior chemotherapy regimen and who are not currently eligible for high-dose (myeloablative) chemotherapy and stem cell transplant.
A multicenter, single-arm, open-label study with pomalidomide in combination with low dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma
Oct 2012Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone(LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.
A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis
Oct 2012To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate dermatitis
The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitis
Oct 2012To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.
A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.
Oct 2012The primary aim of the trial is to assess whether the anticoagulant effects of rivaroxaban are not inferior to those of warfarin. This will be achieved by comparing the percentage change in endogenous thrombin potential (ETP), assessed by the thrombin generation test (TGT), from randomisation to day 42. The TGT is a global measure of anticoagulation, which can assess the anticoagulant effects of both rivaroxaban and warfarin (drugs with very different modes of action on the coagulation mechanism). The TGTs will be performed in the UCL Haemostasis Research Unit.
A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV-1 infected patients.
Oct 2012To see how well the study regime suppresses the HIV-1 virus after 48 weeks of therapy.
A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis
Oct 2012To explore the efficacy of mavrilimumab compared to an anti-TNF antibody in adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two other anti-TNF agents.
An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)
Oct 2012To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission
Pilot study to downregulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass or birch allergen one month in between during the non-seasonal period.
Oct 2012Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.
A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis
Sep 2012Safety Objective: • To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in subjects with UC Efficacy Objective: • Base Phase: To examine the effect of treatment with VB-201 80 mg BID compared to placebo (initial 12 weeks) on measures of disease activity in subjects with UC. • Extension Phase: To examine the effect of longer-term treatment with VB-201 (24 weeks) on measures of disease activity in subjects with UC.
A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)
Sep 2012The primary objective of this study is to assess the therapeutic potential and safety/tolerability of QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard inhaled corticosteroids (ICS) with or without long-acting β2 agonist (±LABA) therapy (Global Initiative for Asthma [GINA] steps 3 and 4)
A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma
Sep 2012The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.
An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
Sep 2012To investigate the clinical efficacy on itch of treatment with cromoglicate cream in subjects with itchy psoriasis
A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis
Sep 2012To evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease
Sep 2012To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8
PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men
Sep 2012The purpose of this pilot is to determine whether it is feasibile to conduct a large trial in the UK to determine whether the immediate inclusion of anti-retroviral pre-exposure prophylaxis (PrEP) as part of the HIV risk reduction package for men who have sex with men is clinically effective and cost-effective in reducing the risk of acquiring HIV.
Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis
Sep 2012To evaluate the changes in molecular pathways of cell adhesion (cellular localization of E-cadherin and ß-catenin) in ulcerative colitis prior to and after treatment with mesalazine (5-ASA)
A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
Sep 2012The primary objective is to assess the efficacy (as measured by the reduction of the signs and symptoms of RA) of JNJ-38518168-ZBQ at doses of 3, 10, and 30 mg/d compared with placebo in subjects with active RA despite concomitant MTX therapy.
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled, Persistent Asthma
Aug 2012To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (≥fluticasone 500 µg or the equivalent daily) and long acting β2 agonists.
Efficacy and pharmacokinetics of a switch from a regimen consisting of emtricitabine, nevirapine and tenofovir to rilpivirine, emtricitabine and tenofovir in virologically suppressed HIV-1 infected patients.
Aug 2012To evaluate the safety of a switch from nevirapine to rilpivarine.
Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy: a randomized, placebo controlled cross over study
Aug 2012Clinical efficacy of Gencydo nasal spray on early allergic response to grass pollen in patients with grass pollen allergy
A safety and efficacy study of adding low dose pegylated ifn-alpha 2b to standard dose dasatinib in patients with newly diagnosed chronic myeloid leukemia
Aug 2012Observe toxicity of drug combination (see protocol) Observe effect measured as response by molecular assessment of BCR-ABL transcript fraction in so called major molecular remission (i.e 3 long below debut levels)
A multi-center, randomized, double-blind, three-arm, 16 week, adaptive phase III clinical study to investigate the efficacy and safety of LAS41008 vs LASW1835 and vs Placebo in patients with moderate to severe plaque psoriasis
Aug 2012The primary objectives of the study are: - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving PASI 75 at week 16 (a 75% reduction in the Psoriasis Area and Severity Index, PASI, compared to baseline. - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving a score of “clear” or ”almost clear” in the Physician’s Global Assessment (PGA) after 16 weeks of treatment. - Non-inferiority of LAS41008 compared to LASW1835 (internal code for Fumaderm®) regarding PASI 75 after 16 weeks of treatment.
Biological standardization of Chenopodium album allergen extract to determine the biological activity in HEP units.
Aug 2012The primary objective is to assess the concentration of Chenopodium album allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
A phase IV study to evaluate decreased dose frequency in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) who experience laboratory abnormalities during treatment with tocilizumab
Aug 2012Efficacy: • To explore the efficacy of TCZ in reduced dosing frequency regimens (Q3W and Q4W, as appropriate) using Juvenile Arthritis Disease Activity Score (JADAS)-71, JIA flare, and fever Pharmacodynamic: • To describe the pharmacodynamics, using sIL-6R and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens.
The Efficacy of Continuous Intra-articular Infusion of Local Anaesthetic Agent following Elective Primary Hip Arthroplasty
Aug 2012To determine whether the use of a continuous intra-articular infusion of local anaesthetic might reduce the need for post-operative opiate use in patients undergoing hip replacement.
Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin
Aug 2012The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores.
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-α Therapy
Aug 2012To determine the effects of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment as measured by ACR20 response. To determine the safety and tolerability of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment.
Immunogenicity of repeated dose 13-valent pneumococcal conjugate vaccine compared to the existing recommended protocol of pneumococcal polysaccharide vaccine in adult kidney and liver transplant patients
Aug 2012To show the non-inferiority of Prevenar 13 compared to pneumovax
Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis
Aug 2012The main objective of the trial is to proof the non-inferiority of an 8-week treatment with three times daily 1000mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis
A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects with Gout
Aug 2012To determine the long-term efficacy and safety of lesinurad monotherapy.
A multicentre, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerT, a combination of contiguous overlapping peptides derived from Bet v 1, in adult subjects allergic to birch pollen
Aug 2012To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab
Aug 2012To study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months.
A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.
Aug 2012To analyse the incidence and outcomes of intercurrent illnesses (other illnesses occurring or recurring) in older HIV-positive people and their relationship with demographic( for example age, gender, ethnicity employment, housing and relationship status) and clinical factors (for example any details of past or present illnesses and treatments). Also history of illnesses within the family.
A multicenter, randomized, double-blind, placebo controlled, 12-week treatment, parallel-group study to assess the efficacy, safety and pharmacokinetics of indacaterol acetate (75 and 150 μg o.d.) in patients with persistent asthma
Aug 2012To demonstrate superiority of indacaterol acetate 75 or 150 μg to placebo with respect to 24 h postdose trough FEV1 after 12 weeks of treatment in patient with persistent asthma.
BE-RELACs-Trial: Biomarkers Explaining RELevance of ACute Rejections
Aug 2012To explore a number of biomarkers from plasma, serum and renal tissue to describe the impact of different strategies for immunosuppression (Belatacept, Cyclosporine) on the immune-system that may explain differences in long-term outcome.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
Aug 2012The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.
A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation.
Aug 2012The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in T1D patients. The safety of reparixin in the specific clinical setting will be also evaluated.
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Aug 2012Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12
Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
Aug 2012The objective of this study is to evaluate the efficacy and safety of BAY 80 6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy.
Combined intra articular corticosteroid and exercise in patients with osteoarthritis of the knee: a randomised trial
Aug 2012To investigate the effect of phsyiotherapeutic exercise in combination with pharmacological antiinflammatory treatment on patient reported pain in patients with knee osteoarthritis.
Efficacy and feasibility of first-line treatment with risk-adapted dose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkitt lymphoma. A phase II clinical trial.
Aug 2012• Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years. • Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an outpatient-clinic basis
A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis
Aug 2012To assess the effects of rFXIII on mucosal healing
Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.
Jul 2012To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction.
Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS)
Jul 2012To evaluate if intestinal wall perfusion, elasticity or peristaltics in patients with CD assessed with the modalities a) dynamic MRI, b) Contrast Enhanced UltraSound (CEUS) or c) Elastography UltraSound (EUS) are correlated to the degree of active or chronic disease and stiffness of tissue.
Optimized Phase III Trial of Immuno-stimulation with Maraviroc, a CCR5 antagonist, combined with Anti Retroviral Therapy (cART) in advanced, Late diagnosed HIV-1 infected patients with an AIDS-defining event and/or CD4 counts below 200 cells/mm3.
Jul 2012To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy in naïve and late diagnosed HIV-1 infected patients. The clinical benefit is the reduction of the occurrence of a composite outcome consisting of new AIDS-defining event (ADE), Non B or C events, serious non-AIDS events, IRIS and death.
BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
Jul 2012The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (breast cancer, Hodgkin's lymphoma).
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)
Jul 2012The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
A 12-Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis with a Long-Term Extension Period
Jul 2012Efficacy of ixekizumab vs. etanercept and placebo in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at week 12
Effect of maraviroc on the transcription of the human immunodeficiency virus type 1 (HIV-1) in resting CD4+ T lymphocytes in patients on antiretroviral treatment with suppressed viral load
Jul 2012To determine if treatment with MVC during a short period of time in patients with previously suppressed viral load by antiretroviral treatment leads to an increase in transcription of latent virus
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Jul 2012The primary objective is to evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Jul 2012To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
Comparison of the Efficacy of Diclofenac Sodium Topical Gel, 1% (Mylan) to Voltaren® Gel, 1% (Novartis US) and Placebo in Adult Subjects with Knee Osteoarthritis
Jul 2012The objective of this study is to investigate the clinical endpoint bioequivalence of Mylan's Diclofenac Sodium Topical Gel, 1% compared to Novartis US’ Voltaren® Gel, 1% and placebo (vehicle, Mylan) following multiple topical applications of 4 g to a single osteoarthritic knee (4 g four times daily for 4 weeks).
A double-blind, placebo controlled, parallel-group, randomised study of safety, tolerability and efficacy of AMAP102 in patients with osteoarthritis.
Jul 2012To assess the efficacy of AMAP102 in patients with pain secondary to osteoarthritis (OA) over 28 days of dosing
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Jul 2012Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12
A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis
Jul 2012To evaluate the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point
Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia
Jul 2012To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.
MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma
Jul 2012To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS) in systemic corticosteroid dependent subjects with severe refractory asthma with elevated eosinophils.
Infliximab Top-down Study in Kids with Crohn’s disease
Jul 2012The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function
Jul 2012Primary Objective: • Phase 0: To determine the receptor occupancy of OPN305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN305 to be used in Part A of the study. • Part A: to select the optimal single IV dose of OPN305 for Part B of the study in ECD/DCD/SCD(CIT>18h) kidney transplantation patients. The primary endpoint for this objective is: o The incidence of DGF on Day 7 defined as the need for dialysis in the 7 days post-transplantation (dDGF) in patients receiving an ECD/DCD/SCD(CIT>18h) kidney transplantation • Part B: to extend the evaluation whether the optimal dose of OPN305 from Part A can reduce the incidence of DGF • Parts A and B: to evaluate whether OPN305 can reduce the incidence of DGF defined as the use of dialysis in the 7 days following transplantation (dDGF) o Note that all three active doses may contribute to this endpoint if similar in efficacy in Part A.
Investigation of a novel intervention in Acute HIV infection (AHI) on long term latent HIV reservoir size: A pilot study of antiretroviral therapy plus immunoglobulin in AHI
Jul 2012To investigate whether reactivation of HIV using immunoglobulin in individuals with AHI and virologically suppressed with ART, will reduce HIV viral reservoir at week 48.
A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate
Jul 2012To investigate the clinical efficacy of NNC0109-0012 compared to placebo when administered as weekly repeat s.c. injections in patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.
A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic Rhinitis
Jul 2012The primary objective is to determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
Jun 2012The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory to an anti-TNF alpha agent.
A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
Jun 2012The objective of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects.
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
Jun 2012To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).
Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to them.
Jun 2012In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.
Personal monitoring of liver transplant patients infected with Hepatitis C Virus. Pilot study to compare the evolution of Hepatitis C by receiving immunosuppression with tacrolimus in combination with Mycophenolate Mofetil or Everolimus.
Jun 2012Compare the evolution of hepatitis C recurrence as determined by progression of liver fibrosis (F ? 2, as ranked by ISHAK) a year post-liver transplantation in patients receiving low dose tacrolimus in combination with mycophenolate mofetil vs everolimus.
A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) + Pharmacogenetics Blood Sample Amendment 01 + UK-specific Amendment 04 (dated 23-Apr-12)
Jun 2012The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn’s disease and who have had an insufficient response to conventional therapy or have failed anti-TNF therapy
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects with Asthma Inadequately Controlled by Corticosteroids
Jun 2012The primary objective of study KB003-04 is to evaluate the effect of KB003 on lung function in subjects with asthma inadequately controlled by corticosteroids, as measured by absolute change in percent predicted FEV1.
Pharmacokinetic interactions between Telaprevir and not powered Atazanavir with ritonavir in co-infected patients with HIV and HCV genotype 1 in treatment for chronic liver disease by HCV
Jun 2012To assess changes in plasma pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered, taking as reference the observed pharmacokinetic parameters when given with Atazanavir/ritonavir 300/ 100 mg per day or Raltegravir.
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma.
Jun 2012To compare the activity of carfilzomib in combination with cyclophosphamide and low dose dexamethasone (CCD) to that of the control treatment of bortezomib, cyclophosphamide and dexamethasone (CVD) in patients with multiple myeloma at first relapse. Specifically the study will assess whether CVD provides non-inferior activity with regard to the short-term outcome measure of ≥Very Good Partial Response rates at 24 weeks, and superior activity in terms of the longer-term outcome measure of progression-free survival.
A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFα biologics
Jun 2012To investigate the clinical efficacy of NNC0109-0012 compared to placebo when administered as weekly repeat s.c. injections in patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFα biologics and are on a stable background of methotrexate (MTX) therapy.
Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis
Jun 2012To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis
Jun 2012To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.
Jun 2012To compare the new adalimumab formulation to the currently approved (current) adalimumab formulation in a dosing regimen of 40 mg eow for 24 weeks
A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy
Jun 2012To evaluate the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011).
A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab
Jun 2012To demonstrate the efficacy of secukinumab 150 mg or 300 mg in subjects with moderate to severe chronic plaque-type psoriasis, who were PASI 75 responders at Week 52 of the core study, with respect to loss of PASI 75 up to Week 68, compared to placebo.
A long-term, open-label follow-up study of CP-690,550 for treatment of juvenile idiopathic arthritis (jia)
Jun 2012The objective of this study is to determine the long term safety and tolerability of CP 690,550 for treatment of the signs and symptoms of JIA.
A phase IIb, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and dosing regimens of MEMP1972A in adults with allergic asthma who are inadequately controlled on inhaled corticosteroids and a second controller (COSTA)
Jun 2012The primary objectives of this study are to evaluate the efficacy and safety of MEMP1972A in adult patients with allergic asthma inadequately controlled despite high dose inhaled corticosteroids ( ICS) (≥ 400 μg/day total daily dose of fluticasone propionate [FP] or equivalent) and a second controller after 36 weeks of treatment.
A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients
Jun 2012The primary objective of this trial is to assess the activity - in terms of percentage of CR - of Clofarabine in combination with Cyclophosphamide in adult patients with refractory and relapsed (≤24 months from first CR) ALL.
A randomized, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma
Jun 2012To demonstrate the non-inferiority of MF 80 µg and 320 µg delivered via Concept1 to MF 200 µg and 800 µg delivered via Twisthaler® in terms of 24 h post-dose trough FEV1 after 4 weeks treatment.
A randomized controlled trial investigating tailored treatment with infliximab for active luminal crohn's disease
May 2012To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorythms in comparison with ‘standard of care’ IFX treatment and its effects on clinical and endoscopic outcomes
A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients
May 2012During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of panobinostat, administered in combination with VTD, in subjects with relapsed and relapsed/refractory multiple myeloma. In the dose expansion phase the purpose of the study is to estimate the response rate (partial response or better) within 16 cycles of VTD-pano at the RD identified in the dose escalation phase.
Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy.
May 2012Co-primary objectives are: 1. To evaluate the rate of MMR at 18 months of nilotinib 300 mg BID monotherapy vs. nilotinib 300 mg BID + pegylated interferon alpha (Peginterferon alpha-2b) 2. To evaluate the rate of continuous MMR after discontinuation of nilotinib vs. interferon alpha.
Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Relapsed Acute Myeloid Leukaemia ineligible for Intensive Chemotherapy
May 2012To evaluate the activity of azacitidine and vorinostat combined therapy, in terms of overall response (OR) (complete remission (CR), complete remission with incomplete blood count recovery (CRi) and partial remission (PR), as defined by Cheson criteria) and overall survival (OS) in patients with relapsed AML who are ineligible for intensive chemotherapy.
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
May 2012The primary objectives are to evaluate the rate of Grade 2 or higher QTcF prolongation and to evaluate the composite complete remission rate (CRc), defined as the confirmed rate of complete remission (CR) plus complete remission with incomplete platelet recovery (CRp) or incomplete hematological recovery (CRi) at different doses of AC220.
The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis. A randomized, double-blinded, placebo-controlled trial.
May 2012In a multicentre, randomized, two-armed, parallel group, double-blind design in patients with early rheumatoid arthritis to investigate whether it is possible by adding tocilizumab to achieve: 1. Inflammatory control as assessed by number of patients who achieve remission (DAS28<2.6) after 12 months of and 2. Sustained remission (DAS28 < 2.6 for 6 consecutive months) after 12 months of treatment and 3. Radiological control assessed by number of patients without radiological progression of the hands/wrists and upper feet from baseline to 12 months of treatment (Increase in total Sharp score (TSS), joint spacing narrowing (JSN) or joint erosions (JE) > 0.5 units)
An open-label multiple dose study to evaluate the pharmacokinetics, safety and tolerability of CP-690,550 in pediatric patients from 2 to less than 18 years of age with Juvenile Idiopathic Arthritis (JIA)
May 2012To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
May 2012To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM)
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
May 2012This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.
Double blind placebo controlled randomized intervention study aiming at reducing dexamethasone related side effects in children with acute lymphoblastic leukemia (ALL).
May 2012To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.
A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis
May 2012To demonstrate the efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis
May 2012To evaluate the long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study.
TAILoR – (TelmisArtan and InsuLin Resistance in HIV): A Dose-Ranging Phase II Randomised Open-Labelled Trial of Telmisartan as a strategy for the Reduction of Insulin Resistance in HIV-Positive Individuals on Combination Antiretroviral Therapy (cART)
May 2012The trial will assess whether telmisartan can reduce insulin resistance (reduced response to insulin) in HIV-positive individuals being treated with combination antiretroviral therapy (cART). Primary objective: To determine the effect of telmisartan on insulin resistance in HIV-positive individuals on combination antiretroviral therapy using HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) as a measurable, validated surrogate marker of insulin resistance.
HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, double-blind, placebo-controlled trial
May 2012The primary question to be answered by this study is whether hydroxychloroquine is an effective treatment for relieving pain in hand OA.
An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)
May 2012To compare the hematological remission, defined as CR (both CR and CRi), as reported by the external independent endpoint adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive active comparator (Arm B).
Lenalidomide and Dexamethasone With/Without Transplant in Patients With Multiple Myeloma
May 2012The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
May 2012The primary objective of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in subjects with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
May 2012To compare progression-free survival (PFS) in patients with multiple myeloma relapsed after 1 to 3 prior therapies treated with either carfilzomib plus dexamethasone (Cd) or bortezomib (Velcade®) plus dexamethasone (Vd).
A randomised, prospective study, assessing changes in cerebral function in treatment naive HIV-1 infected subjects commencing either boosted atazanavir with Truvada or boosted darunavir with maraviroc and Kivexa
May 2012When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death
Apr 2012The primary objective of this study is to evaluate the safety and efficacy of BB3 compared to placebo in improving renal function in the immediate post-transplant period in patients who have received DCD (Donor after Cardiac Death) kidney transplantation.
A randomized, double-blind, parallel-group, placebo-controlled study to assess the safety of REGN668 administered concomitantly with topical corticosteroids to patients with moderate-to-severe Atopic dermatitis
Apr 2012The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).
A Single Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation
Apr 2012To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.
Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)
Apr 2012The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).
The Safety and Efficacy of The Histone Deacetylase Inhibitor Panobinostat for Purging HIV-1 from The Latent Reservoir (CLEAR) Study
Apr 2012A decrease of >0.5 log10 from baseline to week 16 in the size of the latent HIV-reservoir as measured by copies of total proviral HIV-DNA per 10⁶ CD4+ T-cells in HIV-infected patients on suppressive HAART
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)
Apr 2012• To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. • To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE.
A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)
Apr 2012• Evaluate the safety and tolerability of belimumab in the pediatric SLE population • Evaluate the pharmacokinetics of belimumab in the pediatric SLE population. • Evaluate the efficacy of belimumab in the pediatric SLE population • Evaluate the effects of belimumab on the quality of life in the pediatric SLE population.
Study to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients
Apr 2012The primary objective of this study is to evaluate the efficacy of Anakinra in patients with SLE and articular manifestations refractory to conventional treatment.
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Apr 2012The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis
Apr 2012The primary objective is to establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. and to show superiority over vehicle in the treatment of moderate to severe Atopic Dermatitis in adult population.
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia (HOWLONG)
Apr 2012Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).
A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Birch in patients with allergic rhinitis/rhinoconjunctivitis caused by birch pollen
Apr 2012Determination of the optimal effective dose of SUBLIVAC FIX Birch (SB) based on reduction of upper airways reactivity assessed by TNPT after 5 months of treatment with different dosages of SB compared to placebo. Coprimary objective: Difference in proportions of patients not reaching maintenance dose within 10 days due to related AEs of different dosages of SB compared to placebo.
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout
Apr 2012To determine the efficacy of lesinurad by Month 6 when used in combination with febuxostat compared to febuxostat monotherapy
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Apr 2012The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
A 12-month, open label, randomised, effectiveness study to evaluate fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler compared with usual maintenance therapy in subjects with Asthma
Apr 2012The objective of the study is to compare the effectiveness of fluticasone furoate(FF)/vilanterol (VI) Inhalation Powder (FF 100mcg/VI 25mcg or FF 200mcg/VI 25mcg) with usual asthma maintenance therapy over twelve months in a large UK primary care population of subjects with Asthma. FF/VI will be administered once-daily (QD) via the Novel Dry Powder Inhaler (NDPI).
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults
Apr 2012This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.
A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Apr 2012To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.
Apr 2012To evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)
Apr 2012The primary objective of this study is to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following: - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) - Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis) - Immunogenicity (anti-LY2127399 antibodies)
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Apr 2012This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients
BEL114424: A Phase 2 Pilot, Single Centre, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Belimumab plus Standard of Care versus Placebo plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation.
Apr 2012The primary objective of this study is to assess the safety and tolerability of belimumab 10 mg/kg (or placebo) administered in addition to standard of care at transplantation (Day 0), Day 14, Day 28 and every 4 weeks through Week 20.
A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 2/3 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma
Apr 2012The primary objective of Phase 2 is to select a dose of LY2127399 to assess with bortezomib and dexamethasone in Phase 3. The primary objective of Phase 3 is to compare PFS after treatment with the dose of LY2127399 selected in Phase 2, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.
A phase IV, open-label, single centre, single-arm, pilot study to assess Cerebrospinal fluid INflammatory markers after Addition of Maraviroc to MONotherapy darunavir/ritonavir – The CINAMMON Study SSAT046
Apr 2012To investigate changes from week 12 to week 36 in levels of inflammation within the fluid that surrounds the Central Nervous System, called cerebrospinal fluid or CSF, when maraviroc is taken along with regular darunavir/ritonavir monotherapy for 24 weeks.
Investigating the effect of Maraviroc on microbial translocation in HIV-1 infected individuals who are receiving antiretroviral therapy
Apr 2012To determine whether the addition of a CCR5 inhibitor to a stable ART regimen reduces microbial translocation (as determined by plasma bacterial 16s DNA)
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Apr 2012The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
A open-label extension study of CP-690,550 as maintenance therapy in patients with crohn’s disease
Mar 2012The primary objective of the study is to assess the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with CD.
An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Mar 2012To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
A multicenter randomised opened study to assess the efficacy and safety of the withdrawal of nucleos/tide analogues in HIV-1-infected subjects with complete or intermediate resistance to these analogues, multitreated with virological suppression
Mar 2012To assess the safety and efficacy at 48 weeks of withdrawing NRTIs with intermediate or complete resistance in subjects with previous virological failure and a suppressed viral load for > 6 months.
A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis
Mar 2012To evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis
Mar 2012Efficacy of ixekizumab vs. etanercept in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks.
A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
Mar 2012The primary objectives are to assess the safety, tolerability, and efficacy (change from baseline in Disease Activity Score 28 [DAS28] using C-reactive protein [CRP]) of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks compared with placebo in subjects with active RA despite DMARD therapy.
A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 also known as P202)
Mar 2012To compare serious asthma outcomes (a composite endpoint defined as asthmarelated: hospitalizations, intubations, and deaths) in subjects treated with MF/F MDI BID versus subjects treated with MF MDI BID.
Drug Interaction Study of PSI-7977 and Antiretroviral Therapy(ART) Combinations in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients.
Mar 2012This is a drug interaction study between PSI-7977 and antiretroviral therapy (ART) combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/r, Tenofovir and Emtricitabine; in patients co-infected with HIV and HCV. This is an open-label study of approximately 24 healthy HIV/HCV co-infected patients. The study consists of 3 cohorts of 8 patients in each cohort. Patients will be treated with PSI-7977 for 7 days in combination with their ART regimen that the subject has been receiving to manage their HIV infection.
Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma
Mar 2012The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
Mar 2012The primary objective of the study is to assess the effect of tralokinumab compared with placebo in patients with active UC by assessment of clinical response, as defined by the Mayo score, at week 8.
12 month, multi-center, open-label, prospective, randomized, parallel group study investigating a standard regimen in de novo kidney transplant patients versus a Certican® based regimen either in combination with Cyclosporin A or Tacrolimus
Mar 2012To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard group at month 12 post-transplantation in renal transplant patients.
An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis
Mar 2012The primary objective is to assess the number of patients preferring the MTX pre-filled pen to the pre-filled syringe after 6 weeks of treatment.
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects with Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor
Mar 2012To determine the efficacy of lesinurad monotherapy by Month 6 compared to placebo
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen
Mar 2012The primary objective of this study is to compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of UCDAI remission in patients with active, mild or moderate UC.
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
Mar 2012In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy
Mar 2012To determine the optimal dose of MK-8457 + MTX as compared to placebo + MTX, as demonstrated the RA subjects who achieve ACR20 (American College of Rheumatology 20) response after 24 weeks of treatment.
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
Mar 2012Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome. Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB. The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.
Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.
Mar 2012The primary objective of the study is to evaluate the effect of drug delivery method (prefilled syringe or auto-injector) on the PK of tabalumab after the administration of the loading dose in patients with RA who have had an inadequate response to methotrexate (MTX)
An Open Label Phase II Study on the Use of Panobinostat in Combination with Bortezomib and Dexamethasone as Induction in Multiple Myeloma Patients Candidate to High-Dose Therapy
Mar 2012To evaluate if the combination of Panobinostat, Bortezomib and high-dose Dexamethasone as induction therapy can increase the complete response (CR) rate in subjects with previously untreated multiple myeloma who are candidates to autologous stem cell transplantation (ASCT).
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
Mar 2012To determine the best tolerated and effective dose (dose finding) for oral Lenalidomide among 10, 15, 20 e 25 mg dose levels in a 28-day cycle, as associated to a fixed dose of weekly bendamustine (60 mg/m2 on days 1, 8 and 15), based on the best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook in subjects with Recurrent Hodgkin Lymphoma
A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension
Mar 2012To evaluate the efficacy of multiple doses of VX-509 when administered for 12 weeks in subjects with active RA on stable MTX therapy. To evaluate the safety and tolerability of multiple doses of VX-509 when administered for 12 weeks in subjects with active RA on stable MTX therapy.
A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis
Mar 2012To assess the safety and tolerability of long-term CP 690,550 therapy in subjects with UC.
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis
Feb 2012The primary objective of this study is to assess the effect of fostamatinib (100 mg twice daily [bid] taken in combination with a disease-modifying anti-rheumatic drug [DMARD]), relative to placebo plus a DMARD, on mean 24-hour ambulatory systolic blood pressure (SBP) at Week 4, in patients with active rheumatoid arthritis (RA).
Phase 2a Single-Arm Safety Study of Elotuzumab in Combination with Thalidomide and Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma
Feb 2012To determine the safety and tolerability of Thalidomide-dexamethasone-Elotuzumab (TdE) in subjects with relapsed and/or refractory MM as assessed by the incidence of severe (Grade 3 or higher) non-hematologic adverse events (AEs).
Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.
Feb 2012To evaluate the effect of Rifaximin-EIR, administered at a daily dosage of 1,600 mg (2 x 400 mg tablet twice a day) for three months in patients with a moderately active Crohn's disease in terms of clinical response and correlation with endoscopic improvement to Rifaximin-EIR treatment.
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis
Feb 2012The primary objective of this study is to assess the effect of fostamatinib (100 mg twice daily [bid] taken in combination with a disease-modifying anti-rheumatic drug [DMARD]), relative to placebo plus a DMARD, on mean 24-hour ambulatory systolic blood pressure (SBP) at Week 4, in patients with active rheumatoid arthritis (RA).
A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma
Feb 2012To demonstrate the dose-related efficacy by evaluating morning lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) after 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of mometasone furoate (MF) metered dose inhaler (MDI) twice a day (BID) compared with placebo in children 5 to 11 years of age, inclusive, with persistent asthma.
Phase II study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy
Feb 2012To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of 2 different dose levels of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded during the peak of the grass pollen season of each treatment year.
An Open-label, Multicenter Phase 1/2 Study of JNJ-40346527, a FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin’s Lymphoma
Feb 2012Phase 1: To establish the recommended Phase 2 dose for JNJ-40346527. Phase 2: To determine the overall response rate (complete response [CR] + partial response [PR]) in subjects with relapsed or refractory cHL.
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
Feb 2012The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.
Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients
Feb 2012To evaluate the safety and feasibility of intralesional platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology (BTI), for the treatment of perianal fistulas in Crohn's disease.
Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma.
Feb 2012To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)
A double-blind, randomised, placebo controlled, sequential ascending dose study, to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intra-articular doses of fasitibant in patients with symptomatic osteoarthritis of the knee.
Feb 2012To evaluate the safety and tolerability of fasitibant up to 5 mg formulated as 1 mL solution to be given as single intra-articular (IA) administration to patients with knee osteoarthritis.
Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment.
Feb 2012Compare the two treatment groups (ST 261 modified release tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment Evaluation of safety and tolerability of ST 261
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen
Feb 2012The primary objective of this study is to compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of UCDAI remission in patients with active, mild or moderate UC.
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Feb 2012This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Feb 2012This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.
The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantation
Feb 2012To examine the possible renal graft protective effects of treatment with eplerenone in kidney transplanted patients in addition to a standard regimen, including studies in the progression of proteinuria and glomerular filtration.
A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients.
Jan 2012To evaluate the non-inferiority of EVG/COBI/FTC/TDF relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF in maintaining HIV 1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) in virologically suppressed, HIV 1 infected subjects.
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects with Gout who have had an Inadequate Hypouricemic Response to Standard of Care Allopurinol
Jan 2012To determine the efficacy of lesinurad by Month 6 when used in combination with allopurinol compared to allopurinol monotherapy
Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II)
Jan 2012Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks, measured by laser Doppler imaging, in SSc subjects with an early or active SSc pattern, measured with nailfold capillaroscopy (NFM), with ongoing digital ulcer disease and a history of DU disease in the past 2 years.
Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study.
Jan 2012To collect data on knee joint replacement procedures or procedures practiced in the knee (arthroscopy, osteotomy or other) over 5 years in patients with knee osteoarthritis having participated in the CL3-12911-018 study and having received at least one year (365 days) of CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo).
Mechanistic study assessing the immunological response of subjects after treatment with different formulations of sublingual immunotherapy.
Jan 2012To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U.
Pseudohyponatremia of Multiple Myeloma is True Hyponatremia
Jan 2012Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.
A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
Jan 2012To compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
Jan 2012To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis
Jan 2012To demonstrate the efficacy of CP 690,550 in inducing remission in subjects with moderately to severely active ulcerative colitis.
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat (CRYSTAL)
Jan 2012This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.
Effects of losartan and antiretroviral regimen containing raltegravir in fibrosis inflammation mediators, cardiovascular risk and neurocognitive disorders in HIV infected patients previously effectively treated.
Jan 2012Proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
A randomized, multicenter, double-blind, double dummy and parallel study to evaluate the efficacy of the combination of Chondroitin sulfate and Glucosamine hydrochloride in a single dose chewable tablet versus Placebo, using Celecoxib as an active control in patients with knee osteoarthritis with moderate to severe pain.
Jan 2012Evaluate the effectiveness of combination of chondroitin sulphate and Glucosamine hydrochloride in a single chewable tablet versus placebo in the symptomatic treatment of knee osteoarthritis, in patients with moderate to severe pain, using Celecoxib effectiveness as a positive control.
Efficacy and safety of selective vitamin D receptor activation with paricalcitol for reduction of proteinuria in kidney transplant recipients: a randomized controlled trial
Jan 2012Difference in urinary protein to creatinine ratio (UPCR) between paricalcitol and placebo study group patients.
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)
Jan 2012This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.
Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
Jan 2012Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse. It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse.
A 12 month, multi-center, open-label, randomized, controlled study to evaluate efficacy/safety and evolution of renal function of everolimus in co-exposure with tacrolimus in de novo liver transplant recipients
Jan 2012To demonstrate that an immunosuppressive regimen based on everolimus (EVR) in co-exposure with tacrolimus (TAC) has superior efficacy compared to tacrolimus alone on estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver transplant recipients.
A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.
Jan 2012Compare the injection site related pain profile of two different formulations of Humira immediately after injection.
Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Jan 2012Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
an open-label, single-arm, multicenter trial to determine safety and efficacy of eculizumab in the prevention of Antibody Mediated Rejection (AMR) in sensitized recipients of a kidney transplant from a deceased donor
Dec 2011To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
A 3-month, multicenter, randomized, open label study to evaluate the impact of early vs delayed introductioN of EVERolimus on WOUND healing in de novo kidney transplant recipients (NEVERWOUND study)
Dec 2011The primary objective of the study is to compare the proportion of patients without wound complications related to initial transplant surgery (i.e. lymphorrea, fluid collections, wound dehiscence, wound infections, incisional hernia) between the delayed everolimus arm and the immediate everolimus arm, between randomization and 3 months after transplantation.
Protocol I1F-MC-RHAZ A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis
Dec 2011Efficacy of ixekizumab in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks
A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease
Dec 2011To induce clinical response (CDAI decrease from baseline ≥ 100 points) and/or remission (CDAI <150) following 12 weeks of treatment with one of two active doses of GSK1605786A for qualification of subjects for enrolment into a follow-on 52-week maintenance study (CCX114157).
A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease Revised Protocol 01 incorporating Protocol Amendment 02; Pharmacogenetics Blood Sample Amendment 01
Dec 2011The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn’s Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn’s Disease
Evaluation of any steroid sparing effect of beta blocker therapy on airway hyper-responsiveness in stable, mild to moderate, asthmatics.
Dec 2011Do any effects on airway 'twitchiness' in asthma with chronic dosing of beta blockers and low dose steroid inhaler differ with being on a high dose steroid inhaler?
A randomized, double-blind, placebo-controlled, repeat-dose study of the efficacy, safety, tolerability, and pharmacodynamics of subcutaneously-administered REGN668 in adult patients with extrinsic moderate-to-severe atopic dermatitis
Dec 2011The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2011All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B
Dec 2011Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.
HD-R3i - A prospective, randomized, placebo-controlled, international, multicenter phase I/II trial of RAD001 (everolimus) in combination with DHAP as induction therapy in patients with relapsed or refractory Hodgkin Lymphoma
Dec 2011The main objectives of this study are to identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP) and to demonstrate the efficacy of Ever-DHAP as induction therapy
Tasigna in Glivec-resistant or Intolerant Patients in CML
Dec 2011The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.
SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.
Dec 2011The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death).
A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/Refractory Multiple Myeloma.
Dec 2011To compare Progression Free Survival between treatment arms in the overall population.
Optimising outpatient care in mild to moderate psoriasis by a newly developed ‘Topical Treatment Optimising Programme’ - an international study using Daivobet®/Dovobet® Gel (‘PSO-TOP’)
Dec 2011To assess the value of the ‘Topical Treatment Optimising Programme’ in the topical treatment of insufficiently treated mild to moderate psoriasis after 8 weeks of once daily treatment with Daivobet® Gel.
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group Trial
Dec 2011To confirm the rate of acute kidney graft rejection in the study population under standard immunosuppressive therapy in order to corroborate historical renal transplantation statistics and generate reference ranges for future clinical research within The ONE Study.
A single center, randomized, double-blind, placebo-controlled 2-way crossover study to investigate the mechanism of action of etoricoxib in subjects with osteoarthritis knee pain
Nov 2011To assess which pain mechanisms are modulated by 60 mg daily administration of etoricoxib compared to placebo in subjects with osteoarthritic (OA) knee pain during two treatment periods of 4-weeks each.
Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis
Nov 2011The primary objective of this study is to evaluate the safety and tolerability of orally administered LX1606 after 8 weeks in a cohort of subjects with acute, mild to moderate ulcerative colitis.
An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
Nov 2011To confirm long-term efficacy and safety of CT-P13.
HZA106853: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy.
Nov 2011The primary objective is to evaluate the dose response, efficacy and safety of three doses of VI inhalation powder administered once daily in the evening in children aged 5-11 years with persistent uncontrolled asthma over a 4 week treatment period.
A phase III, randomized, active controlled, assessorblinded study of safety and efficacy of Pegylated Apofilgrastim versus US and EU licensed Neulasta® in subjects with stage IIa, IIb or IIIa breast cancer receiving TAC anticancer chemotherapy in adjuvant setting
Nov 2011To demonstrate an equivalent efficacy of Pegylated Apo‐Filgrastim as compared to each of the commercially available US and EU licensed Neulasta® in patients suffering from early breast cancer and receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in adjuvant setting.
A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects.
Nov 2011To demonstrate the non-inferior antiviral activity of DTG 50 mg administered once daily compared to DRV/r 800 mg/100 mg once daily over 48 weeks in HIV-1 infected therapy-naïve subjects.
Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV *).
Nov 2011Evaluate the feasibility and safety of allogeneic MSV applied by percutaneous injection in the knee joint as a treatment for osteoarthritis of the knee
A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma
Nov 2011The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS alone (FP) in pediatric subjects (age 4-11 years) with persistent asthma.
A double-blind, placebo-controlled, study examining the effect of orally administered QAW039 on sputum eosinophil levels and other efficacy outcomes in patients with sputum eosinophilia and persistent asthma
Nov 2011To demonstrate a statistically significant reduction in sputum eosinophil levels in inadequately controlled, moderate-to-severe asthmatics (GINA 2- 5), with sputum eosinophilia after treatment with QAW039 for 12 weeks compared to placebo.
A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml
Nov 2011To assess the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function.
A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.
Nov 2011To investigate the efficacy of GSK1605786 at week 12 following twice daily administration at 500 mg in patients with active Ulcerative Colitis (UC).
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Nov 2011The objective of this study is to see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM)
Nov 2011To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR))
A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.
Nov 2011Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?
E-support for Healthcare Processes - ASTHMA (E-ASTHMA)
Oct 2011The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.
A multicenter, randomized, double blind, comparative trial of maraviroc + darunavir/ritonavir versus emtricitabine/tenofovir + darunavir/ritonavir for the treatment of antiretroviral naïve HIV infected patients with CCR5 tropic HIV 1
Oct 2011To assess whether maraviroc (SelzentryTM, Celsentri®) administered once daily (QD) is non inferior to a reference regimen of emtricitabine/tenofovir administered QD each in combination with darunavir/ritonavir in the treatment of antiretroviral naïve HIV 1 infected subjects as measured by the proportion of subjects with HIV 1 RNA below the limits of assay detection (<50 copies of HIV 1 RNA per milliliter of plasma) at Week 48.
A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Oct 2011This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
Oct 2011To assess whether BMS-817399 in combination with methotrexate is effective in treating moderate to severe rheumatoid arthritis
Pro-Bono 2- A prospective study of loss of bone mineral density in patients with HIV over time: implications for clinical practice and therapeutic options: Vitamin D sub study.
Oct 2011To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
Oct 2011The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
A Randomized, Placebo-controlled, Double-blind, Two-center Study with Denosumab in Subjects Undergoing Elective Total Knee Replacement Surgery
Oct 2011To evaluate the effect of denosumab compared with placebo regarding the maximal total point motion by radiostereometric assay (MTPM by RSA) at one year.
A double blind placebo controlled randomised trial to study the effects of birch pollen specific immunotherapy (BP-SIT) on the symptoms of the oral allergy syndrome in adult patients.
Oct 2011Does immunotherapy (the process of giving small but increasing doses of birch pollen as injections under the skin) improve symptoms of mouth and throat itch, irritation and swelling on eating apples in patients with oral allergy syndrome?
Assessing Decision Maker Tools for Asthma: the Asthma APGAR
Oct 2011This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.
Reduce IDentified UNcontrolled Asthma (RIDUNA)
Oct 2011The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of real-time identification of uncontrolled asthma by electronic administrative records linked to real-time notification of uncontrolled status to patients and asthma specialists with recommended guideline directed intervention by physicians. The investigators hypothesize that real-time outreach following National guideline asthma care recommendations, after real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled corticosteroids will lead to better improvements in asthma control (impairment and risk) compared to standard asthma care outreach.
A two part protocol to assess, using double blind placebo control, the safety, tolerability, and pharmacokinetics of ascending single doses of a new intra-articular administration formulation of SAR113945 (IKK inhibitor) followed by assessment of efficacy, safety, tolerability and pharmacokinetics of a single dose in patients with knee osteoarthritis.
Sep 2011Part 1 TDU11685: assess safety in patients with knee osteoarthritis. Part 2 ACT12505: assess efficacy in patients with knee osteoarthritis
Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis
Sep 2011The specific aims of this study are to compare the changes in knee pain symptoms, physical function, gait parameters and quality of life in persons with knee OA following a standard viscosupplementation injection series of hyaluronic acid (HA) over a one year period.
A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.
Sep 2011To evaluate the efficacy of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no subscore>1) after 10 weeks treatment.
Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma (IHOP)
Sep 2011The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.
An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod)
Sep 2011To study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757
Long-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977)
Sep 2011To evaluate the long term safety of tocilizumab treatment in patients with pcJIA from Germany who entered this extension.
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis (PBFR2)
Sep 2011The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis
Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis
Sep 2011The purpose of this study is to analyze the frequency of the formation of antibodies against three different anti-TNF biologic agents used for the therapy of juvenile idiopathic arthritis.
Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)
Sep 2011This study investigates the hypothesis that bacteria living in a person's mouth and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid Arthritis. The investigators believe that by killing those bacteria with antibiotics, they might be able to understand how the immune system works and, maybe, what causes RA.
An open-label extension study of CACZ885H2356E2 and CACZ885H2357E2 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective
Sep 2011The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 or CACZ885H2357E2.
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO)
Sep 2011This study will examine three different approaches for helping adults manage their OA-related symptoms. The study will compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The interventions are relatively low cost and easy to disseminate, with the patient component being telephone based. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.
An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
Sep 2011The purpose of this extension study is to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit al least pediACR30 response)
United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
Sep 2011The UKALL 2011 trial will examine whether three changes to current standard therapy improves survival and reduces side effects in patients suffering from acute lymphoblastic leukaemia and lymphoblastic lymphoma. The following questions will be answered: 1) Does exposure to the steroid dexamethasone for a shorter period but at a similar total dosage than is currently used during the first month of treatment, result in fewer side effects whilst maintaining efficacy of treatment. 2) Does the use of methotrexate in high dose, reduce risk of relapse involving the central nervous system. 3) Is it possible to omit monthly pulses of vincristine and dexamethasone, currently given for up to 30 months, without increasing the risk of relapse, thereby reducing side effects and improving health related quality of life.
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)
Aug 2011This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy and surgery, and mortality.
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
Aug 2011The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
Aug 2011This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients
Aug 2011To evaluate the induction of clinical remission with Kappaproct given as an add-on treatment in two doses of 30 mg each compared to placebo.
A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma
Aug 2011During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of CHR-3996 and tosedostat administered in combination in subjects with relapsed or refractory multiple myeloma. In the dose expansion phase the purpose of the study is to determine the safety profile of CHR-3996 and tosedostat administered in combination and to estimate the response rate.
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient (TUFEV)
Aug 2011This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
A randomized, double-blind, double-dummy, active controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares, for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective
Aug 2011The two co-primary objectives of this study are: • To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient’s assessment of gout pain intensity in the most affected joint at 72 hours post-dose (on a 0-100mm VAS) • To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks Both co-primary objectives have to be met.
Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)
Aug 2011To evaluate the safety of allopurinol at medically appropriate doses (at least 200 mg daily).
Interferon Responses in Eczema Herpeticum (ADEH) (IFN)
Jul 2011Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-γ plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFN-γ generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-γ induction leads to susceptibility to HSV infection in ADEH+ patients.
A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents
Jul 2011To demonstrate the efficacy of secukinumab (75mg or 150mg) versus placebo (measured with ACR 20) after 24 weeks of treatment
Phase II randomized double-blind placebo-controlled study to evaluate the efficacy and safety of rhumab beta7 in patients with moderate to severe ulcerative colitis
Jul 2011The primary objective of this study is to evaluate the efficacy of different doses of rhuMAb Beta7 compared with placebo in patients with moderate to severe UC.
Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma
Jul 2011The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4, CD47, and beta 2 adrenergic receptors) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma.
Phase 1 Study of Combotox With Cytarabine in Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia (ALL)
Jul 2011This study will test different doses of combotox in your disease to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine. You might have been given cytarabine as part of your treatment for ALL before; even if you have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed"). Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on you and your disease (ALL) when combined with cytarabine.
Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia
Jul 2011The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.
An Analysis of Potential Sex Differences in Knee Osteoarthritis
Jul 2011The purpose of the study will be to investigate if any sex differences can be identified in these tissues and to investigate if there appears to be any relationship between these differences and functional scores and tests.
A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
Jul 2011To evaluate the efficacy in term of progression-free survival after randomization (PFSrand) of a subcutaneous (SC) formulation of rituximab in patients who responded to Induction and initial 2 years maintenance therapy (Maintenance I), and were randomized to either prolonged rituximab maintenance until progression (Maintenance II) or observation.
Phase II randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Rhumab beta7 in patients with moderate to severe ulcerative colitis
Jul 2011The primary objective of this study is to evaluate the efficacy of different doses of rhuMAb Beta7 compared with placebo in patients with moderate to severe UC.
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Jun 2011To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections.
Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept
Jun 2011The StepWatch™ activity monitor (SAM) in an ankle worn step counter and an accurate instrument to measure real world ambulatory activity. The investigators purpose was to investigate whether activities of daily living measured by SAM increase during a therapy with the TNF-alpha inhibitor etanercept in patients with active rheumatoid arthritis (RA).
A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease
Jun 2011The objective of this study is to perform a short-term study to assess how well tolerated combined recombinant growth hormone therapy (rhGH) and insulin-like growth factor (rhIGF-1) therapy is compared to rhGh alone in children/adolescents with Crohn's disease. i.e. will it be acceptable to a child to give two injections in the morning? It is hoped that the results from this phase II study will provide the scientific and safety data to allow us to apply for regulatory permission to move on to a Phase III study of long term growth in children/adolescents whose growth is affected by their inflammatory bowel disease.
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
Jun 2011The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.
Control of moderate or severe asthma with 160, 320 and 640μg ciclesonide/day. A one-year randomised, double-blind, multicenter trial.
Jun 2011The aim of the trial is to investigate whether long-term treatment with 320 and 640μg ciclesonide/day for one year improves asthma control in subjects with lack of asthma control while on 160μg ciclesonide/day. Additionally, the trial will provide further data on the long-term safety and tolerability of ciclesonide.
Comparison of Moisturisers for the Prevention of Atopic Dermatitis Relapse– a Randomised, Double Blind Controlled Study (COMPADRE)
Jun 2011The primary objective is to show that a barrier strengthening moisturiser is superior to a base cream in preventing eczema relapse in patients with AD.
A pilot, explorative study to identify contrast-enhanced ultrasound (CE-US) patterns that characterize acute allograft rejection and other causes of acute allograft dysfunction in renal transplant recipients
Jun 2011To identify the patterns of kidney graft perfusion that are associated with key patterns of renal involvement that may be detected in patients with acute allograft dysfunction.
NK Cell Based Non-Myeloablative Transplantation in (AML) Acute Myeloid Leukemia
Jun 2011This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid leukemia (AML). Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease
Jun 2011The primary objectives are: - To evaluate clinical remission for the 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002. - To evaluate the safety of 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
Jun 2011The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years.
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
Jun 2011The primary objective: Part A / To evaluate the effect of TRK-170 on mucosal healing as measured by Crohn's Disease Endoscopic Index of Severity (CDEIS) score based on ileocolonoscopy and use this evaluation to decide which dose(s) of TRK-170 should be used in Part B Part B / To evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score
A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate
May 2011The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to methotrexate in the treatment of moderate to severe Rheumatoid Arthritis
Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis (ADJUVITE)
May 2011The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm.
The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
May 2011The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
May 2011This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma
May 2011To evaluate two SC treatment regimens of 300 mg tralokinumab compared with placebo by assessing the effect on asthma exacerbation rate over 52 weeks in adults with uncontrolled, severe asthma requiring high-dose ICS and LABA with or without additional asthma controller medications.
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn’s Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2)
May 2011To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active Crohn's Disease where oral ferrous preparations have failed or cannot be used.
Lenalidomide, Lenalidomide + Azacitidine, or Standard Treatment Therapies in Newly Diagnosed Acute Myeloid Leukemia
May 2011The aim of the study is to investigate the effect of a lenalidomide regimen or a sequential azacitidine plus lenalidomide regimen relative to the conventional care regimens in subjects 65 years or older with newly diagnosed Acute Myeloid Leukemia (AML).
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
May 2011The primary objective of this study is to evaluate the efficacy of sifalimumab compared to placebo in subjects with chronic, moderately-to-severely active SLE.
PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
May 2011The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity.
A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension
May 2011To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis after 12 weeks treatment is associated with a certain genetic disposition
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
May 2011The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults
May 2011The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy-A pilot study.
May 2011Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.
Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
May 2011The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis.
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1).
May 2011To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active ulcerative colitis where oral ferrous preparations have failed or cannot be used.
Intramuscular corticosteroid injections in hip osteoarthritis: a double-blinded randomized controlled trial
May 2011To investigate the added effect of an intramuscular gluteal corticosteroid injection on pain symptoms in patients with hip OA, not responding satisfactory to the usual pain medication (acetaminophen or NSAID) at short term (2 weeks).
Patient Activation, Consultation and Exercise - Acute Leukemia (PACE-AL)
May 2011The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
A multicenter, phase III, open-label, randomized study in previously untreated patients with advanced indolent non-hodgkin's lymphoma evaluating the benefit of GA101 (RO5072759) plus chemotherapy compared with rituximab plus chemotherapy followed by GA101 or rituximab maintenance therapy in responders
May 2011Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years
Study of Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Minimal Residual Disease in Acute Myeloid Leukemia
May 2011Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.
An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease
Apr 20111. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study. 2. To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
Twelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia
Apr 2011The primary objective of this study is to evaluate the immunogenicity of long-term treatment of SCN patients with Sandoz’ filgrastim in terms of the incidence of anti-rhG-CSF antibodies.
The effect of GLP-1 in psoriasis
Apr 2011The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.
A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with intravenous BHQ880, a fully human, anti-Dickkopf1 (DKK1) neutralizing antibody in previously untreated patients with high-risk, smoldering multiple myeloma
Apr 2011Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM
Safety of Vorinostat in combination with Bortezomib, Doxorubicin and Dexamethasone (VBDD) in patients with refractory or relapsed multiple myeloma
Apr 2011Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).
A randomized, double-blind, double-dummy, placebo controlled, multicenter study of subcutaneous secukinumab to demonstrate efficacy after twelve weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis.
Apr 2011Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA
Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis
Apr 2011Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.
A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA).
Apr 2011Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke of all classifications
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
Apr 2011To determine if anti-IgE can improve very severe eczema in children, who have not responded to the usual 1st and 2nd line treatments for eczema (assessed by the eczema severity score, SCORAD), as compared to a placebo.
GDC-0449 in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Who Received an Autologous Stem Cell
Apr 2011This phase I trial is studying how well GDC-0449 works in treating patients with high-risk first remission or relapsed multiple myeloma who received an autologous stem cell transplant.
Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Apr 2011Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.
Predicting Response to Azithromycin Therapy in Asthma
Mar 2011The purpose of this study is to better understand the mechanistic effects of Azithromycin (AZM) in asthma, and to establish if AZM therapy is effective in a subgroup of patients with chronic asthma who have phenotypically distinct disease
Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis.
Mar 2011To compare how effective the use of adalimumab, in combination with methotrexate versus methotrexate alone with regard to controlling disease activity in refractory uveitis associated with juvenile idiopathic arthritis.
Treatment Protocol for young adults (18-45 years of age) with Acute Lymphoblastic Leukemia
Mar 2011To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect. To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed. To test if replacing six doses of conventional triple i.t. therapy with DepoCyte® during maintenance therapy for HR-ALL will yield an equal or reduced rate of serious toxicity (SAEs and SUSARs) with a similar or decreased CNS- and overall relapse rate
Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Mar 2011SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
Moderate Rheumatoid Arthritis (RA) With Enbrel
Mar 2011This study is designed to evaluate the effectiveness of adding Etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in subjects with moderately active Rheumatoid Arthritis (RA).
Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial
Mar 2011The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients.
Mar 2011The principal objective is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body. This is called pharmacokinetics (PK). The results will then help to decide how much Modigraf in future should be given to children and young people following transplantation.
Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Mar 2011This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)
Feb 2011The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis.
Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes
Feb 2011this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1)
Feb 2011The primary objective of this study is to evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC as assessed by the proportion of patients who achieve a response as defined by the SRI-5 at Week 52 in patients with SLE. Response is defined as follows: - Reduction of ≥5 points from baseline in SELENA-SLEDAI score; - No new BILAG A or no more than 1 new BILAG B disease activity scores; and - No worsening (defined as an increase of ≥0.3 points from baseline) in PGA.
Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT): A phase 1/2 study of lenalidomide (Revlimid) in combination with cyclophosphamide (endoxan) and prednisone (REP) in relapsed/refractory multiple myeloma
Feb 2011Phase 1 Primary objective - To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. Phase 2 pimary objective - To investigate the efficacy of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone at the RDL, as determined by the (s)CR+VGPR+PR rate.
A 3-Armed Prospective Randomized Controlled, Open-Labeled Phase III Trial to Evaluate Late Introduction of Cyclosporine or Everolimus versus a 5-day Delay of Cyclosporine in Combination with MMF in Liver Transplant Recipients with MELD-Scores≥25
Feb 2011The primary objective of the trial is to investigate the influence of CNI-free-“bottom up” immunosuppression compared to CNI-containing “bottom-up” immunosuppression and 5-day Cyclosporine delay and their influence on renal function at 12 months measured by estimated GFR using the abbreviated MDRD formula
A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)
Feb 2011The primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE.
A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1)
Feb 2011The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.
An Open-Label, Multi-Center Phase I/IIa Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Oral Tasidotin HCL in Patients with Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphomas
Feb 2011To determine the safety and tolerability of Tasidotin HCl administered orally for 14 consecutive days every 28 days cycle by identifying the MTD when administered in patients with relapsed/refractory aggressive non-Hodgkin’s lymphomas
GCPGC in Chemotherapy-induced Neutropenia
Feb 2011This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC and stage II is multi-center, parallel-group, open label,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to daily filgrastim
An open-label, randomized, phase 3 study of inotuzumab ozogamicin administered in combination with rituximab compared to defined investigator’s choice therapy in subjects with relapsed or refractory CD22-positive aggressive non-hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy
Feb 2011To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.
Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
Feb 2011The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.
A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
Feb 2011To evaluate tumor regression as determined by ORR in patients receiving CAL-101 for treatment of iNHL refractory to rituximab and alkylating agents
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Feb 2011The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation
A prospective, randomized, double-blinded, clinical trial, comparing platelet-rich plasma intra-articular knee injections Versus Corticosteroid intra-articular knee injections for knee osteoarthritis
Feb 2011To determine the clinical utility of intra-articular injection of platelet rich plasma in the treatment of osteoarthritis of the knee to the decrease in subjective pain
Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis
Jan 2011To demonstrate the effect of macitentan on the reduction of the cumulative number of new digital ulcers at Week 16 in patients with systemic sclerosis and ongoing digital ulcer (DU) disease.
Oral OKT3 for the Treatment of Active Ulcerative Colitis
Jan 2011This study will assess the safety and efficacy of orally delivered short-term OKT3 in patients with ulcerative colitis.
Smoking young asthmatics: Change of inflammation and quitting cessation rate – effect of Champix
Jan 2011Research of changes in the asthmatic bronchial inflammation before and after tobacco cessation. Success rate of Champix in young asthmatics.
A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.
Jan 2011Eficacia del tratamiento con 162 mg de tocilizumab (TCZ) SC frente a placebo administrados cada dos semanas (C2S) en combinación con FAMEs, en la semana 24 utilizando el ACR20.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2)
Jan 2011The primary objective of this study is to evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC as assessed by the proportion of patients who achieve a response as defined by the SRI-5 at Week 52 in patients with SLE. Response is defined as follows: - Reduction of ≥5 points from baseline in SELENA-SLEDAI score; - No new BILAG A or no more than 1 new BILAG B disease activity scores; and - No worsening (defined as an increase of ≥0.3 points from baseline) in PGA.
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)
Jan 2011The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)
Jan 2011Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics. Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood. The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.
A phase II study to investigate the efficacy of cyclophosphamide as sole graft-versus-host-prophylaxis after allogeneic stem cell transplantation (OCTET-CY)
Jan 2011To assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody. An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial.
Dec 2010The main purpose of this study is to investigate whether rituximab, a new monoclonal antibody used in the treatment of severe rheumatoid arthritis, protects bone. To this end we will measure markers of bone turnover in blood and measure bone density of the spine, forearms and hips with a so-called DEXA scanner before and one year after the first infusion of rituximab.
Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide in Second Line Multiple Myeloma (MM)
Dec 2010To assess efficacy (TTP) of maintenance treatment with lenalidomide alone compared to a regimen with lenalidomide and low dose dexamethasone
Patient Reported Outcomes in Chronic Myeloid Leukemia
Dec 2010The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.
Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)
Dec 2010The primary objective is to characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis (RA).
A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis
Dec 2010To test whether ARA290 reduces 1) diseae activity, 2) disability and 3) systemic inflammation in patients with active RA.
Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes.
Nov 2010To evaluate 1. Response rate: The proportion of patients achieving a complete response (CR) or response (R) during the six month treatment period, for subjects receiving eltrombopag relative to placebo (see Platelet Response Section 5.4.4) 2. Safety and tolerability in terms of frequency of adverse events (AE)s and serious adverse events (SAE), for subjects receiving eltrombopag relative to placebo.
A prospective observational study to evaluate long term safety and functional status of subjects with rheumatoid arthritis previously enrolled in studies of cp-690,550
Nov 2010To estimate the incidences of LPD, lymphoma and important infections over 2 years in subjects with RA who completed or discontinued a qualifying CP 690,550 clinical trial (randomized clinical trial with or without an open label extension).
A prospective observational study to evaluate long term safety and functional status of subjects with rheumatoid arthritis previously enrolled in studies of CP-690,550
Nov 2010To estimate the incidences of LPD, lymphoma and important infections over 2 years in subjects with RA who completed or discontinued a qualifying CP 690,550 clinical trial (randomized clinical trial with or without an open label extension).
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)
Nov 2010The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) (MARVELOUS)
Nov 2010Phase IIIb study to determine early response to certolizumab pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.
The metabolic impact of Darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1-infected patients (MIDAs).
Nov 2010This project aims to assess the potential long-term advantages of switching HIV patients from the standard therapy (Atripla) to a different regime of treatment (darunavir 800 mg / ritonavir 100 mg). This will be assessed by measuring Vitamin D levels, calcium and phosphate homeostasis (balance), kidney (tubular) function, bone turnover and bone mineralisation, and HIV disease progression in all the patients who take part in the study.
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Oct 2010The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)
Oct 2010With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the cells responsible for bone resorption form under the influence of the key osteoclastogenic cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and proresorptive activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG). Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are concurrently down regulated and upregulated respectively. Furthermore, preliminary data in HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART initiation that peaks at 12 weeks and then declines. Based on these findings, the investigators hypothesize HAART associated bone loss is driven by immune reconstitution. Because this effect of HAART is dramatic in magnitude but short in duration, the investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to specifically spare patients from this dramatic but acute bone damage.
Randomised, multi-centre, double-blind, placebo-controlled trial of vitamin d supplementation in adult and adolescent patients with asthma
Oct 2010Does vitamin D supplementation influence time to first severe exacerbation and time to first upper respiratory tract infection in patients with asthma?
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Oct 2010The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1β Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Oct 2010To evaluate the safety, tolerability and immunogenicity of sc administration of ACZ885 in pediatric subjects with active Systemic Juvenile Idiopathic Arthritis (SJIA).
Evaluation de l’efficacité de l’association ibuprofène et codéine versus l’ibuprofène seul dans le traitement de la poussée douloureuse de la gonarthrose. Etude en double aveugle, randomisée contrôlée de 2 groupes parallèles de patients traités pendant 7 jours.
Oct 2010Démontrer la supériorité de l’efficacité de l’ibuprofène codéine (Antarène® Codéine) par rapport a l’ibuprofène seul (Antarène®) dans le traitement de la poussée aiguë de gonarthrose à 4 jours.
Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczema
Oct 2010To test whether combined antibiotics and allergen-immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema.
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma
Oct 2010The primary objective of this study is to determine the optimum dose of bendamustine when combined with thalidomide and dexamethasone (BTD) in the treatment of relapsed/refractory multiple myeloma, based on response rates, tolerability, and progression-free survival (PFS).
Determining the Maximum Tolerated Dose of Low Dose Interferon-alfa in Conjunction With Nilotinib in Imatinib Resistant and/or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) (NICOLI)
Oct 2010This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in imatinib resistant and/or intolerant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
Single center, open-label, cross-over study in maintenace kidney allograft recipients to evaluate the bioavailability of CellCept® (Mycophenolate mofetil) in comparison to Myfortic® (Enteric- coated mycophenolate sodium) in combination with a proton pump inhibitor without co-medication.
Oct 2010The objective of this pharmacokinetic trial is to analyze, whether the concomitant administration of a proton pump inhibitor influences the bioavailability of mycophenolic acid, applied as either mycophenolat mofetil or enteric-coated mycophenolic acid.
Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)
Sep 2010This study is intended to generate first evidence that treatment with etanercept is safe and effective in patients diagnosed with ERA-JIA who are able to aquire stable remission (inactive disease).
A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
Sep 2010The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM).
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
Sep 2010Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.
PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
Sep 2010The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.
HIV-1 Resistance at Screening for HIV Prevention Studies
Sep 2010MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Sep 2010The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole.
Efficacy of Dexamethasone Switch in Prednisolone Resistant Adult ALL and Prolonged L-asparaginase in Non-interrupted Schedule
Aug 2010Evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more. Feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. Tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) Feasibility and efficacy of autologous HSCT for T-cell ALL.
Longterm Effects of Intraarticular Hyaluronan vs Corticosteroid in Osteoarthritis of the Hip: A Randomized Controlled Trial
Aug 2010The primary purpose of the study is to determine the difference in pain reduction and functional recovery between the researchgroups.
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Aug 2010To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma. To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy
Aug 2010The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by ≥ 5 joints with active arthritis despite methotrexate (MTX) therapy for ≥ 3 months.
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma
Aug 2010To evaluate the effect of Lenalidomide given after reduced intensity conditioned stem cell transplant on progression-free survival at 2 years in myeloma
Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A “Proof Of Principle” And Exploratory Trial. (OPTTIRA)
Aug 2010The study investigates whether in it is possible to reduce the dose of or even stop TNF-inhibitors without adversely affecting the control of this disease. This will be assessed by looking at: a. The risk of disease flares (using the disease activity score with a 28 tender and swollen joint count (DAS28). An increase of disease activity score (DAS28) of 0.6 or more represents adversely affecting disease control and is considered a flare) b. If flares are reversed by reverting to the original TNF inhibitor dosage c. If either tapering group show worse key RA assessments including disease activity (DAS28) and disability as measured by health assessment questionnaire (HAQ) scores d. Structural damage (plain hand and feet)
Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma
Aug 2010The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib are effective treatments in patients with previously treated multiple myeloma.
Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
Aug 2010The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (KDD&MSV)
Aug 2010In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence).
A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia.
Aug 2010Assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL) primary objective:-To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
Study to Assess Safety and Tolerability of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Aug 2010The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.
An Open-Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed and/or Refractory Multiple Myeloma
Aug 2010•To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); •To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of two doses of ACT-128800, an oral S1P1 receptor agonist, administered up to twenty-eight weeks in patients with moderate to severe chronic plaque psoriasis
Aug 2010To demonstrate at Week 16 (the end of the induction period) the efficacy of at least one of two doses of ACT 128800 compared to placebo in patients with moderate to severe chronic plaque psoriasis based on the proportion of patients with at least 75% improvement of Psoriasis Area and Severity Index (PASI) from baseline to Week 16.
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
Jul 2010The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.
Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT (PADIMAC)
Jul 2010What is the 2-year progression-free survival (PFS) for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment until clinical indication of relapse? This question is addressed separately for patients who are minimal residual disease positive (MRD+), and those who are MRD negative (MRD-), at end of induction chemotherapy.
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients
Jul 2010The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with chronic myeloid leukemia (CML). The safety of this drug will also be studied.
An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma
Jul 2010•To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) •To assess the safety and tolerability of brentuximab vedotin •In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL).
Jointstrong Intervention for Juvenile Arthritis
Jul 2010The purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can help children learn how to improve their symptoms on their own and reduce the frequency of symptoms.
A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis
Jul 2010The primary objective of this study is to evaluate the long-term safety and tolerability of fostamatinib in patients with active rheumatoid arthritis (RA) by assessment of adverse event (AE) reports, laboratory safety data, vital signs, electrocardiograms (ECGs) and physical examination.
A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist
Jul 2010The primary objective of this study is to evaluate the efficacy of 2 oral dosing regimens of fostamatinib (Regimen A - 100 mg twice daily (bid); Regimen B - induction with 100 mg bid for the first 4 weeks, 150 mg once daily (qd) maintenance thereafter) taken in combination with methotrexate, compared with placebo plus methotrexate, in patients with active rheumatoid arthritis (RA) who have had inadequate response to a single tumour necrosis factor-alpha (TNF-α) antagonist.
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Jul 2010This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses: Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
Jul 2010To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)
A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia
Jun 2010To evaluate the efficacy of blinatumomab to induce complete MRD response
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
Jun 2010This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. The different components of the study will focus on increasing the number of people being tested for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that focuses on HIV prevention.
Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
Jun 2010The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
Evaluate Reversal of Pathological Epidermal Phenotype in Severe Atopic Dermatitis (AD) With Suppression of Immune Activation During Cyclosporine A Therapy
Jun 2010Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects 1-3% of the adults and up to 25% of the children in the United States. Patients with severe AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form) to evaluate the immune suppression and pathological correlation of cyclosporine A in these patients in order to determine the extent to which immune activation drives the pathological epidermal phenotype.
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE)
Jun 2010To evaluate 1. Overall survival (OS) at 2 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive. 2. Disease-free survival (DFS) at 2 years. Events for DFS in both arms are death and first relapse (either AML or MDS recurrence). 3. Changes in quality of life from diagnosis in both arms.
An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximab-refractory, indolent Non-Hodgkin’s Lymphoma
Jun 2010To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy
Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma.
Jun 2010The primary objective of the trial is to evaluate the efficacy of the the house dust mite Allergy Immunotherapy Tablet (6 DU and 12 DU) given once daily compared to placebo in subjects with house dust mite induced asthma, as measured by reducing the risk for an asthma exacerbation.
Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Jun 2010This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation
Jun 2010This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK, JC, CMV, EBV) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML
May 2010For part A of the study (if applicable): 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and select the feasible dose level for part B 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate. For part B: 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) as regards the selected dose level of lenalidomide 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
May 2010Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.
Pharmacological Treatment in Osteoarthritis
May 2010To evaluate the efficacy of hydroxychloroquine 400 mg QD in hand osteoarthritis
Promoting Asthma Wellness in Rural Communities
May 2010This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth: 1. Improving adherence to asthma controller medication use; 2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms; 3. Improving inhaler technique; 4. Smoking reduction or cessation in those who are smokers; and 5. Avoidance of second-hand smoke exposure.
A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis
May 2010To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children.
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (SENSOR)
May 2010To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)
Apr 2010El objetivo principal del estudio es evaluar la seguridad a laro plazo de SAR153191 junto con FARMEs en pacientes con AR.
A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naïve HIV-infected individuals over 96 weeks.
Apr 2010To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
Apr 2010The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma.
Apr 2010The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) (phase II)].
Osteonecrosis in Children With Acute Lymphoblastic Leukemia
Apr 2010Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.
A multicenter extension trial of subcutaneously administered AIN457 in patients with moderate to severe chronic plaque-type psoriasis
Apr 2010To evaluate the long-term safety and tolerability of subcutaneously administered AIN457 in the treatment of moderate to severe chronic plaque-type psoriasis.
An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL)
Apr 2010The primary objective of the study is to determine the efficacy, as measured by overall response (complete response [CR] + partial response [PR]), of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin’s Lymphoma (NHL).
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009)
Mar 2010To compare progression-free survival (PFS) between Arm A and Arm B
Vitamin d effect on T lymphocytes and osteoclastogenesis in rheumaoid arthritis
Mar 2010To evaluate the role of vitamin D as immunomodulator in early RA 3- evaluate the effect of vitamin D on osteoclastogenesis in early RA
A phase 2a proof of concept study comparing three doses of an oral solution of LEO 22811 with a placebo oral solution for the treatment of psoriasis vulgaris
Mar 2010To compare the clinical efficacy of three different doses (0.5 mg, 1.5 mg and 3.0 mg) of an oral solution of LEO 22811 with a placebo oral solution all administered once daily for up to 12 weeks in subjects with psoriasis vulgaris.
Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
Mar 2010In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation? The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks.
Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment with: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF α Therapy (Etanercept, Adalimumab and Infliximab)
Mar 2010This research will be conducted on Dermatology patients diagnosed with "psoriasis" which is a common skin problem adversly affects the quality of life of affected patients.
An open label study of intra-articular steroid injection in the management of symptomatic knee OA
Mar 2010To determine i) whether clinical response to intra-articular steroids in knee OA correlates with a decrease in size and a decrease in perfusion of the synovium. and ii) whether relapse of symptoms after intra-articular steroids is associated with recurrence of synovitis.
Comparison of the effect of Etoricoxib and Diclofenac on early morning activity in RA.
Mar 2010To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.
Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranolol
Mar 2010To establish whether chronic dosing with beta-blockers reduces airway inflammation in mild-to-moderate asthmatics on inhaled corticosteriods.
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
A randomized trial of Rituximab in induction therapy for living donor renal transplantation
Mar 2010Can the addition of rituximab to a minimalist immunosuppressive regimen allow further reduction in immunosuppression?
The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of Prograf and Advagraf
Mar 2010The objectives of this study are 1) To determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics 2) To compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and Imatinib (IM) for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR)
Mar 2010To provide preliminary evidence that HCQ given in combination with imatinib is more effective than imatinib alone in terms of BCR/ABL levels in CML patients who are in major cytogenetic response with residual BCR/ABL+ cells after at least one year of imatinib treatment. To determine the safety and tolerability of HCQ given in combination with imatinib in these patients.
The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.
Mar 2010To test the hypothesis that Globifer Forte treatment leads to a better resolution of anaemia compared to ferrous sulphate in inflammatory bowel disease patients in 12 weeks.
Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma
Mar 2010This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
A Phase 1b/II, Multicenter, Open-Label, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma. Elotuzumab (formerly HuLuc63)
Mar 2010For Phase 1 portion: To identify the maximum tolerated dose of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma. For Phase 2 portion: To evaluate the efficacy of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with multiple myeloma after 1 to 3 prior therapies.
UKALL14 - A randomized trial for adults with newly diagnosed acute lymphoblastic leukemia
Mar 2010To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved event free survival in patients with precursor B-cell ALL (aim 1B). To determine if the addition of nelarabine improves outcome for patients with T cell ALL (aim 1T)
A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
Mar 2010The objective is to compare the efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib (Velcade®) and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches. To assess the safety and tolerability of imatinib in pediatric patients age 1 to less than 4 during the study period.
The predictive value of the acute effect of beclomethasone on a mannitol challenge test for the outcome of lomgterm treatment with beclomethasone
Mar 2010What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a ≥ 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?
A Study on the Prevalence of the Anti-MCV Anti-body in an Irish Rheumatoid Arthritis (RA) Population and the Impact of Biomarker Status on the Management of Irish Patients With Early RA
Mar 2010This study will establish the prevalence of anti-MCV in such a population.
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Feb 2010This Post Marketing Observational Study will be conducted in a prospective, double-arm, single-country, multicenter format. The investigational sites will be centers with experience in the treatment of Rheumatoid Arthritis patients and the anti TNF-a therapy.
An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with acute lymphoblastic leukaemia.
Feb 2010To characterise the bioavailability of a single 50 mg fixed dose of the O4CP innovative oral liquid formulation versus 50mg registered adult tablets and to assess the pharmacokinetics of an adjusted dose of the O4CP innovative oral liquid formulation given daily for 6 weeks
A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Feb 2010To establish effectiveness of ofatumumab in combination with bendamustine in patients with indolent B-cell NHL disease relapsed after rituximab therapy
Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Patients (Aged 12 to 17 Years) with Scalp Psoriasis
Feb 2010The primary objective is to evaluate the safety of once daily use of calcipotriol (50 mcg/g) plus betamethasone (0.5 mg/g) (as dipropionate) gel in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation
Feb 2010To assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are • with t(4;14) translocation (Group 1). • without t(4;14) translocation (Group 2).
A randomized, double blind, placebo and Naproxen controlled, multi-center, study to determine the safety, tolerability, pharmacokinetics and effect on pain of a single intra-articular administration of Canakinumab (anti-IL1β antibody) in patients with osteoarthritis in the knee
Feb 2010Part A : To determine the safety and tolerability of single ascending doses of an intra-articular administration of ACZ885 in subjects with osteoarthritis in the knee. Part B : To evaluate the clinical benefit in subjects with osteoarthritis in the knee, as measured by the change in the pain by using 100 mm VAS scale from baseline to day 4 (primary) and in the Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale from baseline to week 4 (step-down primary) of a single administration of ACZ885 (i.a.) in comparison to placebo.
A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNα-Kinoid in adult patients with Systemic Lupus Erythematosus.
Feb 2010The primary objective of this trial is to assess the safety and tolerability of three administrations of IFN-K adjuvanted with ISA-51 at four doses (30, 60, 120 or 240 mcg), given on SD0, SD7 and SD28 (+/- a fourth dose on SD84 [Month 3]) in adult subjects with SLE.
The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work
Dec 2009Randomized, controlled, double blind multi-center trial, main purpose is toa ssess whether a 6 months treatment adalimumab added on a conventional DMARD therapy will decrease the number of days on sick leave compared to placebo.
LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)
Dec 2009Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).
Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
Dec 2009A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis.
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma (SAPHIRE)
Dec 2009The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast
Dec 2009What is the correlation between change in % fall in FEV1 (∆FEV1) after an exercise challenge 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast?
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma
Dec 2009The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Dec 2009To evaluate the efficacy of pegfilgrastim, as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature ≥ 38.0°C (≥ 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24 hour window of a temperature ≥ 38.0°C or (≥ 100.4°F).
Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
Dec 2009The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas
Dec 2009The primary objective of this study is to test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.
Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)
Dec 2009The primary objective of this study is to evaluate the safety of adalimumab in subjects 2 to < 4 years of age and subjects age 4 and above that weigh < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA.
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome
Dec 2009In this trial, a drug called eculizumab will be tested for its ability to prevent CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an inhibitor of the complement system, which is believed to be important in generating the inflammatory environment that leads to diffuse clotting of blood vessels in CAPS.
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Nov 2009This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia
Nov 2009To determine the maximum-tolerated dose (MTD) in terms of the incidence of dose-limiting toxicity (DLT) of panobinostat in combination with ara-C and mitoxantrone at a fixed dose in adult patients with relapsed or is primary refractory acute myeloid leukemia (AML).
Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplants
Nov 2009The primary aims of the 3C Study are to investigate, in people receiving a kidney transplant, whether: 1) using Campath-1H as induction therapy (i.e. given around the time of transplant surgery) reduces the incidence of acute rejection of the kidney transplant at 6 months after surgery, compared to standard basiliximab-based induction therapy; and 2) whether sirolimus-based maintenance immunosuppression (i.e. the drugs they have to take every day to prevent their body's immune system from attacking ('rejecting') the transplant) improves the function of their kidney transplant, compared to using tacrolimus-based maintenance therapy at 2 years after transplantation.
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation
Nov 2009The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).
Conjoint Analysis of Treatment Preferences for Osteoarthritis
Oct 2009The purpose of this study is to develop a conjoint analysis-based questionnaire and decision aid for patients with osteoarthritis of the knee and to compare the responses of two groups of subjects, one receiving only printed information about knee osteoarthritis, the other participating in a computer-based adaptive conjoint analysis program.
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia
Oct 2009Phase I part: - To assess the MTD and the dose-limiting toxicities (DLTs). Phase II part: - To assess the objective response rate at the recommended dose defined in the phase I part. - To assess the safety and tolerability.
A phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFα biological drug, due to anti-drug antibodies
Oct 2009The primary objective of this study is to identify the best dose and schedule of administration of TNF-K in terms of anti-TNFα antibody response induced by two or three injections of TNF-K (Day 0, 28 or Day 0, 7, 28) at three dose levels (90, 180 or 360 mcg).
A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis
Sep 2009To evaluate the efficacy of CyCol (a controlled release minicapsule formaultion of ciclosporin) in inducing clinical remission, defined as a Disease Activity Index (DAI) score less than or equal to 2 after 4 weeks of treatment, in patients with mild to moderate ulcerative colitis (UC) involving at least the rectum and sigmoid colon, with no individual DAI sub-score >1 at week 4.
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations
Sep 2009• To assess the long-term safety, tolerability, and immunogenicity of canakinumab • To assess efficacy at an exploratory level by investigating disease control defined by maintenance of at least an adapted ACR pediatric 30 during the extension part
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab.
Aug 2009Part I: Primary Objectives: 1. To assess the efficacy of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to signs and symptoms in sJIA patients with persistent activity and an inadequate response to NSAIDs and systemic corticosteroids. 2. To evaluate the short term safety of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to adverse events and laboratory assessments in patients with sJIA with persistent activity and an inadequate response to NSAIDs and corticosteroids. Part II: Primary Objectives: 1. To evaluate the safety of tocilizumab in chronic administration; 2. To assess the effect of tocilizumab to enable the reduction or elimination of corticosteroids Part III: Primary Objectives 1. To assess the long-term safety of 8 mg/kg tocilizumab in children > 30 kg and 12 mg/kg tocilizumab in children < 30 kg with regard to adverse events and laboratory result abnormalities;
A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.
Aug 2009To assess the efficacy of treatment with TCZ monotherapy and TCZ + MTX combination therapy, versus MTX monotherapy, with regard to the following primary endpoint in patients with early, moderate to severe rheumatoid arthritis (RA): Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 6 months.
A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
Aug 2009Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.
Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)
Aug 2009The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.
A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia
Jul 2009To demonstrate that intravenous iron oligosaccharides is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to IBD, evaluated as the ability to increase haemoglobin (Hb).
A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis
Jul 2009To compare the proportion of patients on tocilizumab versus placebo who develop a JIA ACR30 flare (compared to week 16) by week 40.
Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation
Jun 2009This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.
Strategic Timing of AntiRetroviral Treatment (START)
Jun 2009To determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS* (AIDS with an asterisk include most traditional opportunistic conditions but exclude non-fatal esophageal candidiasis and chronic Herpes simplex) non-AIDS, or death from any cause
Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation
Jun 2009To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.
Randomized clinical trial on efficacy and tolerability of intra-articular clodronate compared to placebo in knee osteoarthritis
May 2009Pain reduction based on VAS scale and on joint tenderness evaluation.
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
May 2009This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
May 2009This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
PAVES: Pegfilgrastim Anti-VEGF Evaluation Study
May 2009This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)
May 2009In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
A multicenter, randomized, intra-individual, double blind, vehicle-controlled study to evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks in the treatment of target lesions in adults subjects with atopic dermatitis
May 2009To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis.
A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) response as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis
Apr 2009Efficacy (as assessed by PASI response) of AEB071 in patients with moderate to severe plaque psoriasis as a function of treatment dose and treatment duration.
Effect of macrolides on asthma control, airway inflammation and bacterial colonisation in smokers with asthma
Apr 2009This randomised controlled trial will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.
A prospective, randomized, open label blinded end point (probe), cross-over study to compare the effects of telmisartan and losartan on metabolic profile of renal transplant patients
Mar 2009To compare the short-term effects of telmisartan and losartan on insulin sensitivity in kidney transplant recipients with stable renal function and concomitant treatment with steroids and/or calcineurin inhibitors.
Mycophénolate sodic in graded increased doses in the first 3 months of renal transplantation _ Pharmacokinetic descriptive Pilot study
Mar 2009Describe the pharmacokinetics of the MYFORTIC ® ( MPA) with graded increased doses first 3 months of the renal transplantation
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
Mar 2009The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial
Mar 2009To investigate wheter the concomitant administration of methotrexate leads to a significant prolongation of the efficacy of intrarticular corticosteroid therapy in children with oligoarticular-onset juvenile idiopatic arthritis
A randomized, double-blind, placebo-controlled, parallel group, multi-center study to investigate the safety and efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis
Mar 2009The primary objective is to demonstrate efficacy of CP-690,550 in inducing a clinical response in subjects with moderate-to-severe ulcerative colitis.
An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML)
Mar 2009The primary objective of the trial is to determine the complete response rate (CR/CRi) of older patients with relapsed or refractory AML when given 1 or 2 courses of low-dose Clofarabine combined with Temsirolimus.
A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA) versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
Mar 20092 years diease free survival following first remission achievement (CR or CRp) in younger patients with intermediate-risk or unfavorable-risk AML
Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)
Mar 2009Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that: Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group. Also children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.
Parents, Pediatricians, and Asthma Telephone Coaches Partner to Improve Control of Asthma in Children (The PARTNER Study)
Mar 2009Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Feb 2009Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.
Feb 2009To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention
A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
Feb 2009The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review.
Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Feb 2009This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
A multi-centre, double-blind, placebo-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.
Jan 2009To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.
A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
Jan 2009This 6 arm study will assess the safety and efficacy of RO5072759 given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine, cyclophosphamide) or bendamustine chemotherapy in patients with CD20+ B-cell follicular non-Hodgkin's lymphoma. Patients with relapsed or refractory disease will be assigned by physician choice to either the CHOP treatment arm, to receive a maximum of 8x3weekly cycles of treatment, or the FC treatment arm, to receive a maximum of 6x4weekly cycles of treatment, and will then be randomized to receive combination treatment with RO5072759 either at a dose of 400 mg iv for all infusions, or at a dose of 1600 mg iv for the first 2 infusions, followed by 800 mg for all subsequent infusions. Previously untreated patients will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in combination with bendamustine. The anticipated time on study treatment is 3-27 months.
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Dec 2008Investigators thus plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.
Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma.
Dec 2008To evaluate if 4-weeks treatment with montelukast in children affected by intermittent asthma can significantly reduce levels of TIMP-1 on induced sputum.
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2008All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)
Dec 2008Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis
Nov 2008The primary Objective for the Induction Phase is to determine the effect of MLN0002 induction treatment on clinical response at 6 weeks. The primary Objective for the Maintenance Phase is to determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks.
Effectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis.
Nov 2008The primary objective is to assess whether there is a clinically relevant effectiveness of Diclofenac compared to Paracetamol for a period of two weeks and if necessarily another two weeks (conform Dutch guidelines of the general practitioners) in new consulters with knee OA in the general practice
A Phase II Study of Oral Panobinostat in adult patients with Relapsed/Refractory classical Hodgkin’s Lymphoma after High-dose Chemotherapy with Autologous Stem Cell transplant.
Nov 2008To determine the objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL using modified response criteria for malignant lymphoma
Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
Nov 2008In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
Nov 2008The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia.
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
Nov 2008The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia.
Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkins lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients.
Sep 2008To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET-2 positive), can be salvaged with an early shift to high-dose chemotherapy supported by stem cell rescue.
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
Sep 2008The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.
A study assessing in vivo hepatic and intestinal CYP3A4/5 and PGP activity in kidney transplant recipients and its relationship with genetic and non-genetic variables and the pharmacokinetics and metabolism of Tacrolimus.
Sep 2008To asses in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients.
VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcome
Sep 2008Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo?
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study
Aug 2008To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (sequential high dose cytosine arabinoside and mitoxantrone) versus Standard Double Induction for Initial Chemotherapy of Adult Patients with Acute Myeloid Leukemia
Aug 2008Overall response rate (ORR), aiming at a 15% increase in the CR (complete remission)/CRi (incomplete peripheral recovery) rate by S-HAM induction versus conventional double induction [TAD – HAM for younger patients, HAM (- HAM) for elderly patients].
Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study.
Jul 2008To assess the complete cytogenetic response rate at 12 months
A 24-month extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients
Jul 2008To characterise the general and renal-specific glomerular filtration rate (GFR) (MDRD) safety profile, up to 36 months post transplantation, of renal transplant patients treated with AEB071 in combination with Certican® (CNI free) versus a standard CNI-based regimen.
PPAR-gamma: A noval therapeutic target for asthma
Jul 2008To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma
A phase II multi-center, open-label, study of Nilotinib at a dose of 300mg twice daily in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Jul 2008To establish the Complete Cytogenetic Response Rate at 6 months.
ALFA 0703 : A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Chemotherapy or azacitidine as salvage therapy and Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML)
Jun 2008Untreated AML patients aged more than 65 will be subjected to two randomizations (R1 and R2), in this study. The primary objective of the first randomization (R1) is to assess the benefit in terms of Event Free Survival (EFS) of untreated AML patients aged more than 65 years, treated with induction and consolidation chemotherapy courses, in one arm or with the same chemotherapy courses combined with ATRA in the other arm. The primary objective of the second randomization (R2) is to assess the benefit in terms of Relapse Free Interval (RFI) of maintenance with azacitidine in AML patients in CR, after induction and 4 to 6 consolidation courses of chemotherapy +/- ATRA.
Phase II multicentre clinical study with early treatment intensification in pts with high-risk hodgkin lymphoma, identified as FDG-PET scan positive after two conventional ABDVD courses
Jun 2008Main objective of the trial is to assess the 3years PFS
Macrolides in Refractory Asthma
May 2008To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Apr 2008The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia or lymphoblastic lymphoma.
Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC
Apr 2008To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo.
A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
Apr 2008To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with ulcerative colitis who participated in and successfully completed Study M06-826 (EudraCT number 2006-002781-20) or Study M06-827 (EudraCT number 2006-002782-40).
Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Apr 2008The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.
Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life.
Apr 2008The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Apr 2008A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery rates associated with a Two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Mar 2008This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.
Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
Feb 2008To study the safety of measles, mumps, rubella (MMR) booster vaccination in Juvenile Idiopathic Arthritis (JIA) patients by measuring JIA disease activity.
A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia
Feb 2008To determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL paitent and to confirm safety and efficacy of veltuzumab that was previously established when administered intravenously.
Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
Feb 2008This study will evaluate the safety and effectiveness of granulocyte transfusions in treating people with a bacterial or fungal infection during neutropenia
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia
Feb 2008To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML.
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC 04407)
Feb 2008The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
Jan 2008To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX)
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Jan 2008This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Jan 2008Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.
A prospective randomized study of antibiotic prophylaxis for renal transplantation: short term vs standard treatment
Jan 2008Superiority of single dose - same incidence of infectious complications
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia or High-Risk Myelodysplastic Syndrome
Jan 2008This phase II trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation and donor bone marrow transplant and to see how well they work in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
Efficacy and safety of Alefacept in combination with Tacrolimus, Mycophenolate Mofetil and Steroids in de-novo kidney transplantation – a multicenter, randomized, double-blind, placebo controlled, parallel group study
Dec 2007The primary objective of this study is to evaluate the efficacy and safety of alefacept in a kidney transplant population. Data suggests that 12 weeks of treatment with alefacept in combination with tacrolimus, mycophenolate mofetil (MMF) and steroids may be more effective than and as safe as a combination therapy of tacrolimus with MMF and steroids. Effectiveness will be measured as the occurrence of and time to biopsy proven acute rejection at six months assessed locally.
Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
Dec 2007The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients.
A Combination of Imatinib Mesylate and Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia (UMCC 2006-128)
Dec 2007A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations: A Combination of Imatinib Mesylate & Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia.
High-dose sequential chemotherapy and rituximab (R-HDS) in HIV+ patients with non-hodgkin lymphoma (NHL) refractory or relapsed after 1st line treatment
Dec 2007To assess incidence of infectious complications and mortality after R-HDS in HIV+ patients
Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.
Nov 2007Main objectives of the trial are to determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; and to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and Neutropenia
Nov 2007To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin in subjects with fever and neutropenia with regard to clinical cure versus not cured, after completing the initial course of therapy, without modification.
Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
Oct 2007To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.
Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.
Oct 2007Evaluación de la eficacia y la seguridad de 7 tratamientos GMA (adsorción de granulocitos y monocitos) con Adacolumn durante 7 semanas consecutivas (1/semana) en combinación con la prednisona comparado con un tratamiento con prednisona sola para la inducción y mantenimiento de la remisión de la colitis ulcerosa corticodependiente durante un periodo de 24 semanas.
Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START Protocols: Long Term Safety and Efficacy Analysis.
Oct 2007The primary objective is to determine the long term safety and tolerability of dasatinib. The secondary objective of this study is to collect long term efficacy in terms of molecular response.
Hepatic and intestinal CYP3A4/5 activity in renal transplantation.
Oct 2007To asses in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients at different time-points and in different clinical settings after renal transplantation.
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.
Sep 2007The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis.
Phase ll study evaluating the toxicity and efficacy of a modified German Paediatric Hodgkin's Lymphoma protocol (HD95) in young adults (aged 18-30 years) with Hodgkin's Lymphoma
Sep 2007Main objective of this study is to determine whether young adults (18-30 years) can receive modified HD95 therapy without experiencing excessive neurotoxicity due to the intensive use of Vinca alkaloids in this regimen.
A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular disease
Aug 2007The primary objective is to assess the efficacy of IPH1101 associated with low dose of IL-2 as add-on therapy to imatinib in CML patients with residual molecular disease after at least 2 years of imatinib monotherapy.
A Phase II, Randomized, Placebo-Controlled, Multi-Center Study To Evaluate The Safety, Tolerability, Immunogenicity, And Antiretroviral Activity Of Dermavir (Lc002) Patch In Treatment-Naïve HIV-1-Infected Patients
Aug 2007To evaluate the safety and tolerability of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1. To establish a safe and well tolerated dosing regimen of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1.
A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.
Aug 2007The main objectives of this study are: to assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and to assess in a randomized comparison the effect of bevacizumab on the CR rate.
A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.
Aug 2007To compare the safety and efficacy of a programmed introduction of a Sirolimus-based, Calcineurin inhibitor free, maintenance immunosuppressive regime, three months after renal transplantation in recipients of a non-heart-beating donor kidney graft on: graft function as determined by eGFR and biopsy proven acute rejection rates at twelve months post randomization to programmed Sirolimus introduction
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
Jul 2007To evaluate the safety and the efficacy of 2 SC administered regimens of golimumab in maintaining clinical response through Week 54 in subjects with moderately to severely active UC induced into clinical response with golimumab in the induction studies C0524T16 (EudraCT 2006-003397-94) or C0524T17 (EudraCT 2006-003398-28).
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
Jul 2007Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg
Fatigue and Symptom Burden in Febrile Neutropenia
Jul 2007To determine whether fatigue improves as patients are treated for febrile neutropenia (
Outpatients high-dose chemotherapy supported by autologus peripheral blood stem and single-dose pegfilgrastim in patients with lymphoproliferative malignances.
Jul 2007evaluation of mortality due to febrile neutropenia; evaluation of incidence of febrile neutropenia; percentage of readmissions to the hospital due to febrile neutropenia
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Jun 2007The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
An open label phase II study to evaluate the efficacy and safety of induction and consolidation therapy with dasatinib in combination with chemotherapy in patients aged 55 years and over with philadelphia chromosome positive (PH+ or BCR-ABL+) acute lymphoblastic leukemia (ALL).
Jun 2007To evaluate the efficacy of a dasatinib-based induction and consolidation therapy
Double-Blind, Randomised, Active And Placebo Controlled Study To Assess The Clinical Efficacy, Skin Tolerability And Pharmacological Activity Of A New Topical Compound (Ur-1505 0.5%, 1% And 2%) In Patients With Mild To Moderate Atopic Dermatitis
Jun 2007To explore the clinical efficacy of UR-1505 (0,5%, 1% and 2%) applied once daily during 4 weeks, compared with a vehicle without active ingredients and with an active treatment, in adult patients with mild to moderate atopic dermatitis.
A randomized,open-label,multicenter, parallel-group study of belatacept-based corticosteroid-free regimens in renal transplant
May 2007To assess the rate of AR in different corticosteroid-free belatacept-based immunosuppressive regimens in de novo renal transplant subjects by 6 months post-transplant
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
May 2007This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) who have failed or are intolerant to tyrosine kinase inhibitor therapy
May 2007To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy.
A Phase III randomised, multicentre, double-blind, therapeutic equivalence study of biosimilar G-CSF (PLIVA/Mayne filgrastim) versus Neupogen (filgrastim-Amgen) in subjects receiving doxorubicin and docetaxel as a combination chemotherapy for breast cancer
May 2007To demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim to Neupogen.
The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study
May 2007To investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENESTnd)
May 2007In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Risk of Asthma in Infants With Atopic Dermatitis
Apr 2007Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.
Phase II Multicenter Study Of P210-B3A2 Derived Peptide Vaccine In Chronic Myeloid Leukemia Patients In Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment
Apr 2007The primary objective of the trial is to evaluate the activity of p210-derived peptides vaccinations in terms of BCR-ABL/ ABL ratio reduction at 6 months from the starting of the vaccination program.
Phase II/III Randomized Study of Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Mar 2007Primary (patients considered fit for intensive treatment) Objectives: Compare the efficacy and toxicity of daunorubicin hydrochloride and cytarabine (DA) vs daunorubicin hydrochloride and clofarabine (DClo) as induction therapy in older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. Assess the value of gemtuzumab ozogamicin when given in combination with DA or DClo during course 1 of induction therapy. Compare a total of two vs three courses of treatment in patients who achieve at least partial remission (< 15% blasts) after course 1 of induction therapy. Compare the use of demethylation maintenance therapy comprising azacitidine vs no maintenance therapy in these patients. Assess the value of reduced-intensity allogeneic stem cell transplantation as consolidation in patients with matched donors.
The OPERA Study: a Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Mar 2007Inflammatory control as assessed primarily by number of patients who achieve a DAS28 < 3.2 after 12 and 24 months
A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.
Mar 2007To assess the efficacy and safety of adalimumab for the induction and maintenance of clinical remission in subjects with moderately to severely active ulcerative colitis.
An extension to a phase II open label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis
Mar 2007The objective of this study is to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis.
An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea
Mar 2007The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure.
A Phase II Study Of Velcade Bortezomib - PS341 In The Treatment Of Patients Over 18 Years With Ph Leukemia
Feb 2007The objective of this study is to assess the efficacy and safety of Velcade Bortezomib - PS341 tn the treatment of patients over 18 Years with Ph leukemia.
Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load
Feb 2007To compare the different incidence of virologic failure between the two groups after 12 months from randomization.
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects with Osteoarthritis of the Knee
Jan 2007To determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.
A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Jan 2007To evaluate the efficacy of MK-0457, as defined by major cytogenetic response in chronic phase CML and as major hematological response in accelerated phase CML, blastic phase CML, and Ph+-ALL, when given as a 5-day CIV infusion every 14 days. To evaluate the safety of MK-0457 with this dose and regimen.
Timed-Sequential Induction in CBF-AML
Jan 2007The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.
Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Jan 2007The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.
A multicenter, single-arm, open, conversion study from a cyclosporine (CYA) based immunosuppressive regimen to a tacrolimus modfied release, FK506E (MR4), based immunosuppressive regimen in kidney transplant subjects
Jan 2007Primary objective is to assess the changes in kidney function in kidney transplant subjects converted from a CyA-based immunosuppressive regimen to a tacrolimus modified release, FK506E (MR4), based immunosuppressive regimen.
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
Jan 2007To assess the hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia
Jan 2007To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
LEO19123 Cream in the Treatment of Atopic Dermatitis A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis
Jan 2007To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.
Dec 2006To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Dec 2006The primary objective is to assess the safety of 40 mg basiliximab given intravenously, at 4 week intervals, in ulcerative colitis.
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Dec 2006Primary objectives: To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL. To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse. To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine with or without Tenofovir on the Pharmacokinetics of Atazanavir when given with Ritonavir in HIV-Infected Subjects. Revised Protocol 02 incorporating amendment 03 (Version 1.0, Date 09-Mar-2007) and amendment 04 (Version 1.0, Date 02-Jul-2007). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 5.0, Date 14-Sep-2006).
Oct 2006To assess the effect of multiple-dose FAM BID on the multiple-dose PK of ATV/RTV in HIV-infected subjects when FAM is administered simultaneously (without TDF) or temporally separated (with TDF).
Effect of different meals on the pharmacokinetic profile of Saquinavir at steady state in HIV-infected patients treated with saquinavir/ritonavir 1000/100 mg bid.
Oct 2006To compare the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients taking saquinavir/ritonavir 1000/100 mg with two different meals (low-fat and high-fat meals)
Randomised Trial of Anti-CD20 in C4d+ Chronic Allograft Nephropathy
Oct 2006To determine whether anti-CD20 therapy can stabilise or improve renal function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom standard therapeutic approaches have failed.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)
Oct 2006To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML). Secondary endpoints include duration of treatment response, survival, induction mortality and hospitalizations.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)
Oct 2006To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML)
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutation
Sep 2006To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have the T315I BCR-ABL gene mutation.
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.
Sep 2006The main objective of the study is to evaluate the clinical efficacy and tolerability of the new Low Molecular Weight Heparin 210 mg formulation (CB-01-05-MMX) in patients with active moderate left-sided ulcerative colitis when administered at the daily dose for 8 weeks as an add on therapy to oral mesalazine, and compared to placebo.
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Sep 2006To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.
A two months study of the utility of Elidel cream 1% (pimecrolimus) in the long term management of atopic hand eczema.
Aug 2006To investigate if an Pimecrolimus (pimecrolimus) based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema.
A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma
Apr 2006Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes
Feb 2006To compare the treatment effect of montelukast 10 mg vs. placebo in asthmatic patients who smoke cigarettes, over a 6 month treatment period on the percentage of asthma-control days.
A randomized two-by-two, multi-center, open-label phase 3 study of BMS-354825
Jul 2005The primary objective of this study was to compare the major cytogenetic response
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