CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 835 enrolled
Drug / intervention
Interferon beta-1a +3 moredrug
Likely dose
Not stated in 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/NCT01412333
NCT01412333Phase 3Completed

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

Hoffmann-La Roche·interventional·Posted Aug 9, 2011·Updated Mar 8, 2024

In Brief

A Phase 3 clinical trial evaluating Interferon beta-1a, Ocrelizumab-matching placebo, and 2 other interventions for Relapsing Multiple Sclerosis. Completed, enrolled 835 participants across 165 sites in 24 countries.

Detailed Summary

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Croatia, Czechia, France, Germany, Ireland, Italy, Mexico, Norway, Poland, Russia, Slovakia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartSep 20, 2011
Primary CompletionMay 12, 2015
Study CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.9 years ago

Interventions

Interferon beta-1adrug

Ocrelizumab-matching placebodrug

Ocrelizumabdrug

Interferon beta-1a-matching placebodrug