Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
NCT ID: NCT04869358
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2021-05-27
2023-06-13
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1a
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Cohort 1b
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
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).
Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
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).
Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Interventions
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Ofatumumab
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eligible for ofatumumab treatment
* willing and eligible to receive SARS-CoV-2 mRNA vaccine
Exclusion Criteria
* previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
* no previous vaccination with a non-modRNA SARS-CoV-2 vaccine.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Erbach im Odenwald, , Germany
Novartis Investigative Site
Siegen, , Germany
Novartis Investigative Site
Unterhaching, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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COMB157GDE01
Identifier Type: -
Identifier Source: org_study_id
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