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

• Status: Recruiting
• Trial end date: 2022-11-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: (T,G)-A-L; Glatiramer Acetate; Interferons; Ofatumumab

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

• 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 ≥ 4 weeks OR currently on commercially prescribed interferon or glatiramer acetate for ≥ 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