A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Stopped early · Phase 4

Conditions studied: Relapsing Multiple Sclerosis (RMS)

In brief

This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.

Key facts

Study ID

NCT04878211

Run by

Novartis Pharmaceuticals

People needed

24

Starts

2021-06-10

Expected to finish

2023-04-14

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study
• Diagnosis of relapsing MS by 2017 revised McDonald criteria
• Were willing to comply with the study schedule
• Cohort 1: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) at least two weeks prior to starting ofatumumab
• Cohort 2: Were receiving an mRNA COVID-19 vaccine (Pfizer or Moderna vaccine) and on ofatumumab for at least 4 weeks
• Cohort 3: Were 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

You may not qualify if…

• Received the J\&J vaccine.
• Had a contraindication to receiving an mRNA COVID-19 vaccine
• Had an immediate allergic reaction to past vaccine or injection
• Experienced a major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit

Where it is running

• Center For Neurology and Spine — Phoenix, Arizona, United States
• Infinity Clinical Research LLC . — Hollywood, Florida, United States
• Dragonfly Research LLC — Wellesley, Massachusetts, United States
• Minnesota Center Multiple Sclerosis — Plymouth, Minnesota, United States
• The MS Center for Innovation in Care — St Louis, Missouri, United States
• The Neurological Institute PA — Charlotte, North Carolina, United States
• Dayton Center for Neurological Disorders — Centerville, Ohio, United States

Full record on ClinicalTrials.gov

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