Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
The study will provide efficacy, safety, tolerability and pharmacokinetics data for ofatumumab 20 mg subcutaneous injections every 4 weeks compared with placebo for 24 weeks in patients from Japan and the other countries and also provide the extended efficacy, safety, tolerability and pharmacokinetics data.
This study has 2 parts: A controlled Core and an open-label Extension.
- Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability and PK of ofatumumab in patients with relapsing MS.
- Extension part: The Core part is followed by an Extension part in which all patients receive open-label ofatumumab. In the Extension part, patients are treated for at least 24 weeks and no longer than 48 weeks.
Approximately 60 patients will be randomized in a 2:1 ratio to ofatumumab or placebo in the Core part; half of the study patients will be from Japan and the other half from the other countries.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 60 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab
Actual Study Start Date: March 15, 2018
Estimated Primary Completion Date: November 25, 2019
Estimated Study Completion Date: May 11, 2020
- Experimental: Ofatumumab arm
- Placebo Comparator: Placebo arm
|Date last updated at source||2019-05-15|
|Study start date||2018-03-15|
|Estimated primary completion date||2019-11-25|