A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
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- STATUS
- Recruiting
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- End date
- Aug 30, 2023
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- participants needed
- 66
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- sponsor
- Novartis Pharmaceuticals
Summary
This study will evaluate if participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly can develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
Description
This is a three-cohort, multicenter, prospective study of up to 66 relapsing MS participants. The first cohort will be participants receiving an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. The second cohort will be participants receiving an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. The third cohort will be participants currently on an interferon or glatiramer acetate planning to receive COVID-19 mRNA vaccine. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.
Details
| Condition | Relapsing Multiple Sclerosis (RMS) |
|---|---|
| Treatment | Ofatumumab, mRNA COVID-19 vaccine, interferon or glatiramer acetate |
| Clinical Study Identifier | NCT04878211 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 4 October 2022 |
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