Multiple Sclerosis Clinical Trial
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
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 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.
Signed informed consent must be obtained prior to participation in the study
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Willing to comply with the study schedule
Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
Eligible to receive and plan to be started on ofatumumab OR currently on prescribed ofatumumab for â‰¥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for â‰¥ 4 weeks
Already has received Pfizer, Moderna or Johnson & Johnson vaccine
Known diagnosis of COVID-19 prior to screening
Has a contraindication to receiving an mRNA COVID-19 vaccine
Has an immediate allergic reaction to past vaccine or injection
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
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There are 8 Locations for this study
Phoenix Arizona, 85032, United States
Sunrise Florida, 33351, United States
Wellesley Massachusetts, 02481, United States
Plymouth Minnesota, 55446, United States
Saint Louis Missouri, 63131, United States
Charlotte North Carolina, 28204, United States
Centerville Ohio, 45459, United States
Knoxville Tennessee, 37922, United States
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