CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 955 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/NCT02792231
NCT02792231Phase 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 Nov 22, 2021

In Brief

A Phase 3 clinical trial evaluating Ofatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, and 2 other interventions for Relapsing Multiple Scelrosis. Completed, enrolled 955 participants across 178 sites in 30 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 Scelrosis
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, India, Italy, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 7, 2016
Enrollment StartAug 26, 2016
Primary CompletionJul 10, 2019
Study CompletionOct 22, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.1 years ago

Interventions

Ofatumumab subcutaneous injectiondrug

Ofatumumab 20 mg prefilled 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