NCT04847596

A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Ofatumumab	Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
OTHER	Covid-19 vaccine	Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.

Timeline

• Start date: 2021-05-21
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-04-19
• Last updated: 2023-01-25

Locations

5 sites across 2 countries: United States, Puerto Rico