Relapsing Multiple Sclerosis (RMS) Clinical Trial
Official title:
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
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.
This is a six-cohort, multicenter, prospective study of up to 88 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. The fourth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. The fifth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and currently on interferon or glatiramer acetate. The sixth cohort will be participants fully vaccinated with an RNA COVID-19 vaccine and received a booster dose at least four weeks after ofatumumab start. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program. ;
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