Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
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 16 months. The f...
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 16 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 six months after the participants' vaccination.
Tracking Information
- NCT #
- NCT04869358
- Collaborators
- Not Provided
- Investigators
- Not Provided
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