A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
ClinicalTrials.gov Identifier: NCT04878211
Novartis Reference Number: COMB157GUS16
Last Update: Jan 20, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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.
Interventions
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
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]