Multiple Sclerosis Clinical Trial
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
Cohort 1: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
Cohort 2: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
Cohort 3: Will be receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on interferon or glatiramer acetate for at least 4 weeks
Cohort 4: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
Cohort 5: Fully vaccinated with a non-live COVID mRNA vaccine (Pfizer or Moderna vaccine), with or without a booster, and on interferon or glatiramer acetate for at least 4 weeks
Cohort 6: Fully vaccinated with a non-live COVID mRNA vaccine, (Pfizer or Moderna vaccine), with a booster, and on ofatumumab for at least 4 weeks
Exclusion Criteria:
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 7 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
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