Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
연구 개요
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). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.
- 스폰서
- 리드: 노바티스
- 적응증
- Relapsing Multiple Sclerosis
- 중재
- Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV), 23-valent pneumococcal polysaccharide vaccine (23-PPV), Seasonal Quadrivalent influenza vaccine, Keyhole limpet hemocyanin (KLH) neo-antigen
- 목표 등록
- 1,882명
- 시작일
- 2018-12-28
- 완료(예정)
- 2028-09-30
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