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

Last updated: May 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Ofatumumab

Clinical Study ID

NCT04869358
COMB157GDE01
  • Ages 18-100
  • All Genders

Study Summary

This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsing Multiple Sclerosis (RMS) diagnosis

  • eligible for ofatumumab treatment

  • willing and eligible to receive SARS-CoV-2 mRNA vaccine

Exclusion

Exclusion Criteria:

  • known prior or current COVID-19 infection

  • previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab

  • no previous vaccination with a non-modRNA SARS-CoV-2 vaccine.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase: 4
Study Start date:
May 27, 2021
Estimated Completion Date:
June 13, 2023

Study Description

This was a four cohort, multicenter, open-label, prospective study of 34 (optionally up to 60) patients who had relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient was 22 months.

  • The first cohort was RMS patients receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine prior to starting ofatumumab treatment.

  • The second cohort was participants receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).

Cohort 1a - Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.

Cohort 1b - Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.

Cohort 2a - Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

Cohort 2b - Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

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

Connect with a study center

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bielefeld, D 33647
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erbach, 64711
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Siegen, 57076
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89073
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unterhaching, 82008
    Germany

    Site Not Available

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