CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 930 enrolled
Drug / intervention
Ofatumumab subcutaneous injection +3 moredrug
Likely dose
Ofatumumab subcutaneous injection 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.

Search/NCT02792218
NCT02792218Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

Novartis Pharmaceuticals·interventional·Posted Jun 7, 2016·Updated Oct 1, 2021

In Brief

A Phase 3 clinical trial evaluating Ofatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, and 2 other interventions for Relapsing Multiple Sclerosis. Completed, enrolled 930 participants across 166 sites in 29 countries.

Detailed Summary

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Russia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 7, 2016
Enrollment StartSep 20, 2016
Primary CompletionJul 5, 2019
Study CompletionJul 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.1 years ago

Interventions

Ofatumumab subcutaneous injectiondrug

Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter

Teriflunomide-matching placebo capsulesdrug

Placebo capsule, matching in appearance to teriflunomide, taken orally once daily

Teriflunomide capsuledrug

Teriflunomide 14 mg oral capsule taken once daily

Matching placebo of ofatumumab subcutaneous injectionsdrug

Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter