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

TerminatedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis (RMS)

Interventions: Ofatumumab, mRNA COVID-19 vaccine, interferon or glatiramer acetate

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
* 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

Exclusion Criteria:

* 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

Locations (7)

Phoenix, Arizona, United States
Hollywood, Florida, United States
Wellesley, Massachusetts, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Charlotte, North Carolina, United States
Centerville, Ohio, United States