NCT01247324

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 821 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon beta-1a
DRUG	Ocrelizumab-matching placebo
DRUG	Ocrelizumab
DRUG	Interferon beta-1a-matching placebo

Timeline

• Start date: 2011-08-31
• Primary completion: 2015-04-02
• Completion: 2022-12-31
• First posted: 2010-11-24
• Last updated: 2024-03-04
• Results posted: 2017-07-18

Locations

142 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Russia, Serbia, Slovakia, South Africa, Spain, Switzerland, Tunisia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study