drugset / Trial / NCT04878211

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

NCT04878211 ↗

Phase 4 Terminated 24 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.

Timeline

Start
2021-06-10
Primary completion
2023-04-14
Completion
2023-04-14

Outcome

Outcome not reported

Stopped (Business): “Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.”

Drugs

EvaluationDrugModalityDoseRoute
Subject COVID-19 mRNA vaccine Vaccine — —
Subject Glatiramer Acetate Small molecule — —
Subject Interferon Unknown — —
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous

Indications