Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

  • End date
    Jan 16, 2023
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 September 2021
relapsing multiple sclerosis


This study aims to understand whether patients with MS can mount an immune response to SARS-CoV-2 mRNA vaccines when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.


This is a two cohort, multicenter, open-label, prospective study of 40 (optionally up to 60) patients with relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination as part of clinical routine. The maximal duration of the study for an individual patient is 22 months.

  • The first cohort will be RMS patients receiving SARS-CoV-2 mRNA vaccine as part of clinical routine prior to starting ofatumumab treatment.
  • The second cohort will be participants receiving SARS-CoV-2 mRNA vaccine as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).

Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies will be investigated for up to 18 months after the participants' vaccination.

Condition Multiple Sclerosis, multiple sclerosis (ms)
Treatment Ofatumumab
Clinical Study IdentifierNCT04869358
SponsorNovartis Pharmaceuticals
Last Modified on22 September 2021


Yes No Not Sure

Inclusion Criteria

Relapsing Multiple Sclerosis (RMS) diagnosis
eligible for ofatumumab treatment
willing and eligible to receive SARS-CoV-2 mRNA vaccine

Exclusion Criteria

known prior or current COVID-19 infection
previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
Other protocol-defined inclusion/exclusion criteria may apply
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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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