Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Summary

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

Timeline

Start

2018-03-15

Primary completion

2019-12-26

Completion

2020-07-29

Outcome

Met primary endpoint

registry analysis (superiority test); OMB 20 mg vs Placebo; p <0.001; Rate ratio 0.064 (95% CI 0.018 to 0.232); negative binominal regression model NCT03249714 ↗

Drugs

Indications