An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
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.
Inclusion Criteria:
Exclusion Criteria:
Vaccination sub-study:
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Neuburg A.d. Donau, Bavaria 86633, Germany
Chandigarh, Punjab 160012, India
Sefad, 1311300, Israel
Shiwa-Gun, Iwate 0283695, Japan
Shinjuku-ku, Tokyo 1608582, Japan
Sittard-Geleen, Limburg 6162 BG, Netherlands
Glogow Wielkopolski, 36-060, Poland