At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
Ofatumumab +1 moredrug
Likely dose
Ofatumumab 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ofatumumab and Matching placebo of ofatumumab for Relapsing Multiple Sclerosis. Completed, enrolled 64 participants across 14 sites in 2 countries.
Detailed Summary
The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesJapan, Russia
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartMar 2018
Primary CompletionDec 2019
Study CompletionJul 2020
TodayJul 2026
First PostedAug 15, 2017
Enrollment StartMar 15, 2018
Primary CompletionDec 26, 2019
Study CompletionJul 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago
Interventions
Ofatumumabdrug
Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content)
Matching placebo of ofatumumabdrug
Matching placebo in pre-filled syringes