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.
1mg Vial
subcutaneous injection of 20 mg ofatumumab every 4 weeks
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
0.5mL Vial/Syringe
0.5mL Vial/Syringe
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
San Miguel de Tucumán, Argentina