Clinical Trials
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Musculoskeletal Disorders
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).
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.
Craniosacral Therapy to Treat Chronic Low Back Pain
Mar 2013The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.
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)
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Mar 2013Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money. We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis
Mar 2013The aim of this study is to investigate the effect of daily supplementation with 3 g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and inflammation in patients with psoriatic arthritis.
Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome (D-Lay-MS)
Mar 2013The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).
Sub-thalamic Nucleus Stimulation in Parkinson Disease (PARKEO)
Mar 2013Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology. A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator. Clinical results will be assessed at 6 months after implantation.
Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)
Mar 2013The investigators recently completed one of the first feasibility/safety trials in the world of reparative bone marrow cell therapy in 6 patients with longstanding MS (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and intensive repeated tests on the patients measuring nerve conduction in various pathways in the brain and in the spinal cord showed statistically significant improvements at 12 months in every patient. While highly preliminary and involving only a very small number of patients, these results at least raise the possibility of a significant (though very partial) underlying repair effect within the damaged nervous system. The investigators believe this urgently requires further testing - both to accelerate benefit for patients, and to begin improving therapeutic efficacy. The investigators therefore propose a programme of translational and clinical stem cell research, aiming (1) to continue translation with a phase two controlled trial of bone marrow cells in patients with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by studying bone marrow cells from treated patients and control subjects, aiming to establish which of the various relevant bone marrow subpopulations contribute to efficacy, and which particular reparative mechanism(s) are important. The investigators hope these studies will not only confirm the therapeutic benefit of this approach, but also provide the basis for improving the magnitude and impact of this novel and exciting treatment modality.
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy (GONDOPARK)
Mar 2013The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
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.
Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis
Mar 2013This is a Multicenter, randomized, double-blind study in subjects with moderate to severe non-radiographic Axial Spondyloarthritis. There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled period for subjects who meet the randomization criteria. Subjects who flare during the double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Mar 2013The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Mar 2013This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity, paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of Th1 and Th17 mechanisms. Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each dosing session they will receive study treatment in a 3:1 ratio of active: placebo respectively. Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio to A or P. Each subject will receive the same study treatment for repeated doses. If the duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12 subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses. Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by a dose escalation committee.
Mortality Following Surgery for Proximal Femoral Fractures (HipMo)
Mar 2013Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).
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.
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population (CONTROL)
Mar 2013This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)
Mar 2013Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces. Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures. Primary hypothesis: In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
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.
Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma (SERIO)
Mar 2013This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.
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).
Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain (POETS)
Feb 2013The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality (SEPREV)
Feb 2013Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.
Study of the Efficacy of Manual Therapy for a Subgroup of Acute Non-specific Low Back Pain
Feb 2013The purpose of this study is to validate or not the interest of the classification using the pragmatic application of clinical predictive rule for low back pain to identify patients with good prognosis following a brief spinal manipulation intervention.
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
Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis
Feb 2013This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.
Manipulative Therapy Techniques to Treat Chronic Low Back Pain
Feb 2013The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.
Hip Fractures Treated With Uncemented Arthroplasties (HUA)
Feb 2013The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations (Vibrioception)
Feb 2013The primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration.
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Feb 2013There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.
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
EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD (EEGDBSNAd)
Feb 2013Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al 2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007; Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive models of executive control mechanisms are incomplete. 2) From a methodological point of view, investigating cerebral activity during STN-DBS is very limited because most techniques are incompatible with locally implanted electrodes. This project relies on a double opportunity to answer these questions offered by recent theoretical and methodological advances. First, investigations in healthy subjects (Jaffard et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory control, so far ignored, consisting in locking in advance movement triggering processes to prevent undesired automatic or anticipated responses to unattended stimuli. In other words, key processes of executive control may act tonically before stimulation occurs, calling brain imaging studies to look at proactive and not only reactive activations. Second, recent advances in EEG signal processing now allow suppressing from the electroencephalogram DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a non-invasive technique with the high temporal resolution necessary to disentangle proactive from reactive brain activity. To our knowledge, up to date no study has been published using EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from this first part of the project may help resolving other long-lasting issues. Indeed, reactivity as assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication. Since the proactive activity related to executive, inhibitory, control may be supported by the noradrenergic (NA) system, the second purpose of this project is to test the original hypothesis according to which NA plays a central role in both akinesia and STN-DBS side effects.
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Feb 2013The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device (RebiQoL)
Feb 2013This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.
Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. (MSREPAIR)
Feb 2013This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
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.
Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls
Feb 2013Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions: Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls? Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?
Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Feb 2013Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on fingolimod treated kidney transplant patients showed that NK cells were not influenced in any of the treatment groups. However, more recent reports indicate an increased frequency of NK cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors seems to increase during NK cell maturation. Thus, different NK cell sub-types may response differently to S1P-receptor agonist such as fingolimod. Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the effects of fingolimod on NK cell maturation/differentiation.
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.
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.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.
"Cognitive Functional Therapy" vs. Manual Therapy for Non-specific Low Back Pain
Jan 2013This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises to a classification based biopsychosocial intervention (a cognitive/functional approach) as described by Peter O`Sullivan, on a subgroup called "flexion pattern" This pilot study has three specific aims: (i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed. (ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments. (iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking
Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults (FUBEO)
Jan 2013The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery. Second purpose : to define apparent diffusion coefficient value of the bone sarcoma. Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Jan 2013This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland
Jan 2013The aim of this investigation is to determine whether the use of painPREMIER will significantly improve function in patients with low back pain in an occupational health clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of back pain and associated problems in order to treat them most effectively.
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Jan 2013Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area. The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Jan 2013The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Respiratory Function and Walking Capacity in Multiple Sclerosis
Jan 2013Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages. The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.
Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
Jan 2013This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate.
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)
Jan 2013The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.
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.
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.
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.
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.
Decoding Chronic Pain With fMRI
Jan 2013Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.
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.
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
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.
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 the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
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.
Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE)
Jan 2013The purpose of this study is to determine whether raltegravir is effective in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced MRI.
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).
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 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
RETREAT(F) (REmoval of Treatment for patients in REmission in psoriatic ArThritis – Feasibility study). A randomised controlled trial to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis – feasibility study, RCT Arm
Dec 2012For this feasibility study we wish to know the proportion of eligible patients who are willing to undergo treatment withdrawal and the proportion remaining in minimal disease at the end of the study period. Within the three month treatment withdrawal period, a minimal disease activity (MDA) score of 5 or more (achievement of the minimal disease activity criteria) will be used to confirm continuing low disease activity. A person not achieving the MDA criteria at any of the monthly assessment time points will be deemed to be experiencing a flare of their disease. The proportion of patients who flare will also be used to inform the full 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)
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 Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood
Nov 2012To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson?s disease
A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.
Nov 2012This is a feasibility study designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor.
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).
The effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery
Nov 2012To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery
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 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
A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Nov 2012To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.
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.
ITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis
Oct 2012To assess long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS.
Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
Oct 2012The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain to obtain a market authorization in Germany for this indication.
A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
Oct 2012To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
Effect of fingolimod on cardiac autonomic regulation in MS-patients
Oct 2012To evaluate whether fingolimod has an effect on the heart rate variability or myocardial ventricular repolarisation in patients with multiple sclerosis?
Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain
Oct 2012The objective of this trial is to assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 μg, 400 μg, and 600 μg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
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.
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis
Sep 2012Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)
Sep 2012This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
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
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)
Sep 2012The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
Sep 2012Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation. A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants. The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
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 phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis
Sep 2012To evaluate the safety, tolerability and effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters.
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.
Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture (FEMO)
Aug 2012This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.
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.
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.
Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
Aug 2012Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department. All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients` satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age). Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.
Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.
Aug 2012To assess the non-inferiority of clinical and radiological efficacy of the treatment with lower-high dose of oMP (625mg/day for 3 days) vs high dose of oMP (1250mg/day for 3 days) in patients in relapse of MS, 28 days after the treatment.
FDDNP-PET for in vivo diagnosis of Tauopathy in unclassifiable parkinsonism
Aug 2012To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP
Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain
Aug 2012The objective of this trial is to assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 μg, 400 μg, and 600 μg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
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.
A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma
Aug 2012To compare the efficacy and tollerability of two chemotherapeutic regimens (either Cyclophosphamide+ Etoposide or high dose Ifosfamide) currently used to treat relapsed Osteosarcoma patients
efficacy of rotigotine on gait performance of parkinsonian patients
Jul 2012Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis
Jul 2012Measure the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)
Jul 2012The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are: To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, subjects’ global impression of change in walking To evaluate the safety and tolerability of prolonged-release fampridine.
Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab
Jul 2012Determine the difference in the incidence rate of uveitis in subjects with Ankylosing Spondylitis (AS), before and after treatment with golimumab
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 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.
Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study
Jun 2012To assess the effect of intra-venously applied autologous MSCs on cerebral inflammation in multiple sclerosis patients
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.
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
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
Jun 2012To assess acute and long-term safety and overall survival in patients with castration-resistant (hormone-refractory) prostate cancer.
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.
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)
Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity (SPACING)
May 2012Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.
Evaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy
May 2012The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
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 Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
May 2012To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients with Chronic Heart Failure
May 2012The primary outcome is Peak VO2O2 consumption/workload relation during submaximal exercise.
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.
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.
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 randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen.
May 2012This study seeks to assess the benefit of rivastigmine (a drug which augments mental function) on gait (walking) dysfunction in patients with Parkinson’s disease (PD) with a past history of a fall. The primary aim is to determine the effect of the cholinesterase inhibitor (ChEi) rivastigmine on step time variability in patients with PD. Step time variability is a marker of how stable an individual's walking is and a prognostic marker for future falls risk.
A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease
May 2012To assess the effect of q2 weekly intermittent bilateral intraputamenal GDNF infusions on OFF-state motor function at 9 months.
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (POSTURE)
Apr 2012Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying
Apr 2012To measure the effect of co-administration of GSK962040 on levodopa pharmacokinetic exposure in subjects with Parkinson’s disease with delayed gastric emptying
The effect of a single skin treatment with Capsaicine 8% in low back pain
Apr 2012We want to demonstrate the efficacy of a single skin treatment with capsaicin 8% patch (Qutenza®) in patients suffering from low back pain with a neuropathic pain component according to the classification of symptoms with the Pain Detect questionnaire (scores > 18, neuropathic pain) compared to patients without a clear neuropathic pain component (scores ≤ 18 -13).
Phase II multicentric and prospective trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma
Apr 2012Analyze progression free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.
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
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis
Apr 2012To evaluate the efficacy of apremilast 30 mg twice a day (BID), compared with placebo, in the reduction of signs and symptoms in subjects with active AS at 16 weeks of treatment
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects with Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy
Apr 2012To assess the analgesic efficacy of OXN compared to placebo in opioid-experienced subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy and To assess the efficacy of OXN for the management of opioid-induced constipation (OIC) compared with OXY in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the clock opioid therapy.
Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing
Apr 2012To determine the effect of 6 months of treatment with teriparatide 20 μg/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)
Apr 2012To evaluate the incidence of patients with bradycardia (heart rate < 40 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.
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 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 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.
Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma A Multi-Institutional Cross-Discipline Non-Therapeutic Study
Mar 2012To evaluate the effect of gender on the pharmacokinetics (PK) of doxorubicin in AYA* patients with newly diagnosed: -Ewing family of tumours (EFT)** -Osteosarcoma (OS); or -Hodgkin lymphoma (HL) *AYA is defined as young people who have entered puberty (Tanner stage ≥2) or are pubertally mature, regardless of whether they are being treated on an adult chemotherapy regimen or a children’s chemotherapy regimen. **EFT includes Ewing’s sarcoma of bone, extra-osseous Ewing Sarcoma, and PNET (primitive neuroectodermal tumour) outside the central nervous system.
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 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.
A multi-centre, double-blind, randomised, parallel group study to assess the efficacy and safety of multiple doses of topically applied hyperemisation-inducing ointment (2 cm ointment line per application; up to 3 times daily for up to 4 days) containing 2.5% Nicoboxil/0.4% Nonivamide versus 2.5% Nicoboxil, 0.4% Nonivamide and placebo in patients 18 to 65 years of age with acute low back pain
Mar 2012The objective of this trial is to demonstrate superior efficacy of a hyperemisation-inducing ointment containing 2.5% Nicoboxil/0.4% Nonivamide over 2.5% Nicoboxil and 0.4% Nonivamide and placebo for the treatment of acute low back pain in patients aged 18 to 65 years
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)
The Parkinson's Progression Markers Initiative (PPMI)
Mar 2012To identify clinical, imaging and biologic markers pf Parkinson Disease (PD) progression for use in clinical trials of disease-modifying therapies.
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-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).
Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.
Feb 2012To assess whether tranexamic acid or fibrin glue administered topically reduce by at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.
An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias
Feb 2012To evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by •Incidence and severity of adverse events and serious adverse events •Changes in vital signs, laboratory assessments, and ECGs •Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson’s Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD
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 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.
The effect of 1-84 parathyroidhormone in the treatment of proximal fracture of the humerus.
Feb 2012To assess the value of treatment with Preotact in patients with humerus fracture.
Effect of Teriparatide on Femoral Neck Fracture Healing
Feb 2012To determine the effect of 6 months of treatment with teriparatide 20 μg/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.
Feb 2012To assess the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on 1. Upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). 2. Scores of the MSIS-29 (physical), MSWS-12 and the Disabilities of the Arm, Shoulder and Hand Score (DASH)
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
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
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).
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.
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.
Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
Jan 2012To study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease.
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.
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.
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Jan 2012To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD)
Dec 2011Is the cholinesterase inhibitor drug donepezil hydrochloride superior to placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson’s disease and mild dementia after 24 months of treatment?
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
Dec 2011To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Dec 2011This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma.
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma
Dec 2011The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein
Effectiveness of leech therapy in treatment of chronic low back pain - a randomised controlled clinical study
Dec 2011Changes in the VAS (100mm) pain score 7 days after leech treatment
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.
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.
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
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Nov 2011There is a need to evaluate the current diagnostic and treatment practices in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries, with special focus on the use of conventional disease modifying antirheumatic drugs (DMARDs) and biologic agents. Further, it is necessary to establish the long-term clinical outcomes of adalimumab therapy in routine clinical practice, in particular its sustained effectiveness, impact on extra-articular manifestations (EAMs), co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) and work productivity.
Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.
Nov 2011To investigate whether hyperbaric oxygen therapy in patients with open fracture of tibia grade II and III decreases the rate of surgical complications (necrosis, dehiscence, infection).
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis
Oct 2011The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma (ISG/OS-2)
Oct 2011The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein
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
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 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 multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain
Sep 2011To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits.
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.
Acupuncture in Acute Nonspecific Low Back Pain (Acuback)
Sep 2011The investigators aim to explore whether acupuncture treatment has effect on time to recovery as an addition to the standard treatment in general practice according to national guidelines.
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)
A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease
Aug 2011To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.
Is regional anaethesia of the hip preferable over traditional analgesia in the acute stage of the management of patients with a fracture of the hip?
Aug 2011Pain management in patients with a fracture of the hip
Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer
Aug 2011To facilitate the access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale
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.
Fractures and Bisphosphonates: A double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures
Aug 2011The aim of the study is to determine if alendronic acid - the drug most commonly used in the UK as treatment of osteoporosis (thinning bones) - affects fracture healing. Participants will be randomised to receive either alendronic acid or a placebo (a tablet that contains no active drug). The main objective will be to look at the x-rays that are taken 4 weeks into the study and compare the number of healed fractures in each group (alendronic acid or placebo). We will also look at how long it takes a fracture to heal, using the x-rays taken at weeks 2, 4, 6 and 8. One person will analyse all the x-rays in the study. The x-rays will be anonymised so that the reviewer is unaware of individual details or the treatment that the participant received.
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).
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
A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis
Jul 2011To demonstrate that the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active Ankylosing Spondylitis based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve
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.
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).
UsTekinumab for the treatment Of Patients with active Ankylosing Spondylitis (TOPAS) – a 28-week, prospective, open-label, proof-of-concept study
Jun 2011Evaluation of efficacy and safety of ustekinumab 90 mg administered subcutaneosly at week 0, week 4 and week 16 in patients with active AS (the Bath Ancylosing Spondylitis Disease Activity Index – BASDAI ≥4) fulfilling the modified New York criteria who have had an inadequate response to ≥2 NSAIDs or do not tolerate or have a contraindication for NSAIDs.
Collaborative Care for Older Adults With Back Pain (COCOA)
Jun 2011The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration.
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.
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias
May 2011To assess the anti-dyskinetic efficacy of multiple doses of AQW051 in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the modified Abnormal Involuntary Movement Scale (mAIMS). To assess the anti-parkinsonian effect of multiple doses of AQW051 in combination with L-dopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the Unified Parkinson’s Disease Rating Scale (UPDRS) – part III. To assess the safety and tolerability of multiple doses of AQW051 in combination with Ldopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias.
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
Observational Cohort Study of Chronic Low Back Pain
May 2011This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 150 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 150 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.
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).
Rasagiline treatment for Sleep disorders in Parkinson´s disease
Apr 2011Reduction of sleep disturbances
A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD)
Apr 2011To demonstrate that transdermal nicotine treatment retards disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).
Yoga vs. Physical Therapy for Chronic Low Back Pain in Minority Populations
Apr 2011The application's primary aim is to determine the comparative effectiveness of yoga, physical therapy, and education for three outcomes at 12 weeks: pain intensity, back-specific function, and use of pain medication. For each of these outcomes, patients randomized to the yoga group are hypothesized to demonstrate clinically and statistically greater improvements than patients in the physical therapy or education groups. After the 12 week intervention period, half of the yoga and physical therapy participants will be randomly selected to participate in a 40 week ongoing structured yoga or physical therapy maintenance program. Pain, function, and pain medication use will be compared between maintenance and non-maintenance groups. Cost and utilization data will also be collected so cost effectiveness analyses from the perspective of society, the third party payer, and the patient can be performed. Together, results from these studies will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain.
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
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.
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).
High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy.
Feb 2011To evaluate the effects on brain activation patterns of drugs that are widely used in clinical practice for the treatment of fatigue in multiple sclerosis
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
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.
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.
A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta.
Dec 2010Assess the effect of Teriflunomide in comparison to placebo on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β).
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease (rTMS)
Dec 2010This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients.
An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonβ-1a (IFNβ-1a, Rebif®) therapy in the induction of tolerance to IFNβ in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNβ-1a (Rebif® or Avonex®)
Dec 2010Perform a “proof-of-concept” phase IIa clinical trial to induce tolerance to IFNβ in subjects with NAbs to IFNβ-1a.
Pioglitazone in Early Parkinson's Disease
Dec 2010This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.
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.
Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with “wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study.
Nov 2010To investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg), administered once a day, compared with placebo when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations.
Sensory Attention Focused Exercise in Parkinson's Disease
Nov 2010The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.
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).
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.
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.
A two-phased, randomized, double blind, placebo-controlled study of ECP002A (Δ9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain.
Oct 2010Evaluation of the efficacy of ECP002A (Δ9-THC) on spasticity in patients with MS
Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.
Oct 2010Main objective of the trial is the creation of "metabolic profiles" of two important pillars of therapy of Morbus Parkinson, namely Levodopa (+ Benserazide) and Rotigotin. The main focus is on the investigation of stress parameters and nerval growth factors, which are suspected of provoking neural lesions or may counteract such impairments.
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).
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Oct 2010The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session).
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.
Vercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)
Oct 2010The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
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).
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer
Sep 2010To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Sep 2010This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice
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.
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.
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)
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 Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks
Aug 2010To determine whether PYM50028 exhibits clinical benefit in the treatment of subjects with early-stage Parkinson’s disease (PD), as assessed by the Unified Parkinson’s Disease Rating Scale score for Parts II and III combined (UPDRS II/III), compared with placebo.
A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy
Aug 2010To assess the: efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who have had an inadequate response to TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24) and the safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and laboratory assessments
A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy
Aug 2010To assess the: efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who are naïve to treatment with TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24) and the safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and laboratory assessments
Intradiscal Methylene Blue Injection Treatment for Chronic Discogenic Low back pain A prospective Clinical Series followed by a Randomised Placebo-Controlled Clinical Trial
Jul 2010The Randomized Clinical Trial (RCT) aims to prove the hypothesis that Intradiscal Methylene blue Injection is capable of better pain reduction than the best available treatment in patients suffering from axial low back pain of discogenic origin
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 Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)
Jul 2010The primary efficacy objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson's disease as measured by the sum of UPDRS Parts 2 and 3 scores. The primary safety objective of this trial is to evaluate the safety and tolerability of preladenant compared to placebo in subjects with early PD.
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.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson's Disease.
May 2010To evaluate the long-term safety and clinical utility of IPX066 in subjects with Parkinson´s disease (PD).
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
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.
Randomized Double-blind Study Comparing the Efficacy of Duloxetine with Placebo in Patients with Chronic Low Back Pain
Apr 2010• Weekly mean of VAS-Score in the last week of each treatment period • Use of rescue medication
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Apr 2010To assess the effects of strontium ranelate in the management of aseptic fractures of the lower limbs with delayed union or non-union.
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
Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma
Mar 2010The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.
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.
Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells
Mar 2010To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
Mar 2010To investigate the effect of AMG 785 compared to placebo on functional healing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy hip fractures.
An international, multi-centre, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.
Mar 2010The primary objective is to evaluate the incidence of post-operative delirium (POD, diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia, with Xenon or Sevolfurane, for a period of four days post-surgery
The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis
Mar 2010The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression.
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
Mar 2010The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Repetitive Transcranial MAgnetic STimulation (rTMS) for MotoR and Mood Symptoms of Parkinson's Disease (MASTER-PD), a Multicenter Clinical Trial
Mar 2010The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor (movement) and mood symptoms due to Parkinson's disease (PD).
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.
Safety and Effectiveness of Adalimumab (Humira) in Patients With Ankylosing Spondylitis in Clinical Routine
Mar 2010The objectives of this PMOS are to: - document clinical practice patterns for treating patients with ankylosing spondylitis - demonstrate long-term efficacy and safety of HUMIRA in patients with ankylosing spondylitis under routine conditions
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.
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.
Genomic Analysis of Pediatric Bone Tumors
Jan 2010To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).
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.
A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)
Dec 2009The primary objective of the study is to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing Spondylitis)
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.
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.
An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis
Oct 2009To assess the safety and tolerability of AIN457 in patients with moderate to severe ankylosing spondylitis receiving i.v. AIN457 initially up to 6 months (part1) with a possible extension of a further 6 months (part2) in patients who participated in the core CAIN457A2209 phase II proof-of-concept study
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).
T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents.
Oct 2009The primary objective of our research is to determine the effect of anti-TNF-alpha treatment on the levels of a cell type of the immune system, called Th17 cells and their product, IL-17 in blood samples and joint biopsies from patients with rheumatoid arthritis at different time points during treatment and how these changes correlate with parameters of systemic and local disease activity.
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
Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients
Sep 2009To evaluate the long-term safety and tolerability of safinamide (50-100 mg p.o., q. d.) in PD patients.
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.
An open-label Phase IIa, non-randomised, study of Alpharadin in breast cancer patients with bone dominant disease who are no longer considered suitable for endocrine therapy
Jul 2009To investigate if multiple intravenous injections of Alpharadin have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy.
A multicentre, double-blind, randomised, active- and placebo-controlled clinical trial on the pain relieving effects of the modfied-release formulation of flupirtine in patients suffering from moderate to severe chronic low back pain
Jul 2009The primary objectives of this study are to demonstrate either non-inferior pain relieving effects of the modified-release formulation of flupirtine (400mg OD in the evening) in comparison to extended-release tramadol (200mg OD in the evening) as well as a superior analgesic efficacy of flupirtine MR (400mg OD in the evening) in comparison to placebo in patients suffering from moderate to severe chronic low back pain (CLBP) after a four week treatment course.
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.
An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study
May 2009To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long term benefits over delayed-start, and to investigate the long-term effects of rasagiline in PD subjects who participated in the ADAGIO study and have continued on rasagiline treatment.
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.
Association Between Low Back Pain and Quality of Sleep
May 2009A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.
A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease
May 2009To compare the effect of REQUIP® CR and IR on the discomfort induced by global daytime somnolence in PD patients suffering from REQUIP® IR induced daytime somnolence.
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
May 2009The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma
May 2009To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease (NICOPARK2)
Mar 2009The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect.
Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: “freezing of gait and glutamate: FOGG-I”
Mar 2009analyse de la marche (longueur du pas) avec le système optoélectronique (Vicon®) sur les phases d’initiation et de marche lancée
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
Evaluation de la captation d'un radioligand des transporteurs de la dopamine chez des sujets atteints de la maladie de Parkison et présentant ou non des douleurs en rapport avec cette pathologie.
Mar 2009L’objectif principal de ce travail est d’étudier la corrélation entre le degré de dénervation de la voie nigro striée objectivée par une scintigraphie cérébrale marquée au FP-CIT et le seuil subjectif de perception douloureuse évalué en thermotest chez des patients parkinsoniens placés en condition médicament OFF
Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain
Feb 2009The main purposes of this study: to investigate if rehabilitation programs specifically focusing on the return to work process will reduce sickness absence and disability pension in patients with neck and low back pain. To assess the work-, individual- and health factors and their interrelationship predicting sickness absence and work disability. To compare results from the rehabilitation program with results from rehabilitation program in Toronto. To which extent are the patients met by actions from employers and employment services, and does is influence sickness absence and disability and do these actions represent favourable cost benefit for the work places and the society?
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
An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers (PRESLO)
Oct 2008The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.
Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.
Oct 2008To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy.
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Sep 2008The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).
A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatib) in Reducing the Risk of Bone Metastases and Prolonging Disease-Free Survival in Women with Breast Cancer
Jul 2008The main objectives of the trial are: To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing a first bone metastasis (first disease recurrence) compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily on disease-free survival compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 250 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo. To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo
Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients.
Jun 2008Comparaison du score moteur de l'échelle UPDRS (score III) mesuré en état "defined OFF " à la dose maximale de nicotine administrée après 20 semaines de traitement en comparaison au groupe témoin.
Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
May 2008The purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. Conventional methods such as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict chemotherapy response in osteosarcoma.
Antibiotic treatment of patients with low back pain and Modic changes after a lumbar disc herniation. A randomized clinical controlled trial.
May 2008The aim of this study is to evaluate the efficacy of antibiotic treatment to patients with Low Back Pain and Modic changes after a lumbar disc herniation, and to evaluate if there is a dose-response relationship in different doses of antibiotics.
Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2
Apr 2008Ankylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms.
A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases.
Mar 2008To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).
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 II, Randomised, Open-label, Pilot Study to Evaluate the Safety and the Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone Disease
Feb 2008To estimate the effect of AZD0530 plus standard of care (SoC) compared with zoledronic acid plus SoC on bone resorption by assessment of serum beta Cterminal cross-linking telopeptide of Type I collagen (βCTx)
Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone
Feb 2008Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.
Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.
Dec 2007To evaluate the efficacy of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease.
Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastased experiencing moderate to severe bone pain.
May 2007The primary objective is to establish the efficacy of ibandronic acid in patients with lung cancer and painful metastatic bone disease and pain responses over a 7 day period.
Phase III Randomized Study of Combination Chemotherapy With or Without Zoledronic Acid in Patients With Osteosarcoma
May 2007Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid.
Effet du methotrexate sur la relation dose - effet de l'infliximab dans la spondylarthrite ankylosante
Apr 2007Quantifier l'influence du méthotrexate sur la pharmacocinétique de l'infliximab dans la spondylarthrite ankylosante.
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
Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab
Mar 2007The primary objective of this study is to assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in patient treated with infliximab
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 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus
Nov 2006Demonstrate that fracture union is accelerated in subjects with humeral fractures (proximal, shaft) treated with conservative (nonoperative) therapy SOC and a single dose of rhBMP-2/CPM (either 1.0 or 2.0 mg/mL) compared to subjects who are treated with SOC alone
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain
Nov 2006The primary objective of this study is to assess the efficacy of duloxetine 60 mg once daily (QD) to 120 mg QD compared with placebo on the reduction of pain severity as measured by the weekly mean of the 24-hour average pain scores in patients with chronic low back pain (CLBP) during a 13-week, double-blind acute treatment period using an 11-point Likert scale and an electronic patient diary.
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD)
Sep 2006Main objective: To assess the safety, tolerability, and biochemical efficacy (changes in urinary NTx) of MK-0822 in women with breast cancer and MBD. Secondary objectives: To assess the efficacy of MK-0822 on additional biochemical parameters and its pharmakokinetic properties
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma
Jul 2006To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg.
May 2006Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer.
May 2006To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression in subjects with advanced breast cancer and bone metastases.
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer
Feb 2006To compare the treatment effect of AMG 162 with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.
A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of 60 - 80 mg/day as oxycodone / naloxone prolonged release (OXN) compared to subjects taking oxycodone prolonged release tablets alone.
Jan 2006The primary objective of this study is to demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation as measured by the bowel function index (BFI) compared to subjects taking oxycodone prolonged release tablets alone.
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