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

• Status: Recruiting
• Trial end date: 2023-01-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ofatumumab

Criteria

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