Status:
COMPLETED
Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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 vaccina...
Detailed 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 (in...
Eligibility Criteria
Inclusion
- Relapsing Multiple Sclerosis (RMS) diagnosis
- eligible for ofatumumab treatment
- willing and eligible to receive SARS-CoV-2 mRNA vaccine
Exclusion
- 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
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04869358
Start Date
May 27 2021
End Date
June 13 2023
Last Update
May 16 2025
Active Locations (6)
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1
Novartis Investigative Site
Berlin, Germany, 13353
2
Novartis Investigative Site
Bielefeld, Germany, D 33647
3
Novartis Investigative Site
Dresden, Germany, 01307
4
Novartis Investigative Site
Erbach im Odenwald, Germany, 64711