Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

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). 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.

Timeline

Start

2018-12-28

Primary completion

2028-09-30

Completion

2028-09-30

Publications

• Hauser SL, Cohen JA, de Seze J, Meuth SG, Giacomini PS, Nakahara J, Oreja-Guevara C, Robertson D, Wray S, Bhatt A, Hu X, Xi J, Piccolo R, Jehl V, Sullivan R, Boer I, Wiendl H, Kappos L. Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis. Neurol Ther. 2025 Oct;14(5):1975-1992. doi: 10.1007/s40120-025-00784-0. Epub 2025 Jul 13.
• Hauser SL, Zielman R, Das Gupta A, Xi J, Stoneman D, Karlsson G, Robertson D, Cohen JA, Kappos L. Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension. Mult Scler. 2023 Oct;29(11-12):1452-1464. doi: 10.1177/13524585231195346. Epub 2023 Sep 11.

Drugs

Indications