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

NCT04869358

CompletedPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis

Interventions: Ofatumumab

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Other protocol-defined inclusion/exclusion criteria may apply

Locations (6)

Berlin, Germany
Bielefeld, Germany
Dresden, Germany
Erbach im Odenwald, Germany
Siegen, Germany
Unterhaching, Germany