Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)
ClinicalTrials.gov ID: NCT03650114
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals (Responsible Party)
Last Update Posted: 2023-07-17
Brief Summary:
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.
Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).
OFFICIAL TITLE
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
INTERVENTION / TREATMENT
Biological: Ofatumumab
Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)
Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Biological: Seasonal Quadrivalent influenza vaccine
Biological: Keyhole limpet hemocyanin (KLH) neo-antigen
| Category | Value |
|---|---|
| Study Start (Actual) | 2018-12-28 |
| Primary Completion (Estimated) | 2027-12-30 |
| Study Completion (Estimated) | 2028-09-07 |
| Enrollment (Estimated) | 2060 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | COMB157G2399 |