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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2022
  • participants needed
    66
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 August 2021

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.

Description

This is a three-cohort, multicenter, prospective study of up to 66 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. Participants will obtain the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.

Details
Condition Relapsing Multiple Sclerosis
Treatment Ofatumumab, mRNA COVID-19 vaccine, interferon or glatiramer acetate
Clinical Study IdentifierNCT04878211
SponsorNovartis Pharmaceuticals
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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