NCT01412333

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: 835 (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).

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: 2011-09-20
• Primary completion: 2015-05-12
• Completion: 2022-12-30
• First posted: 2011-08-09
• Last updated: 2024-03-08
• Results posted: 2017-07-18

Locations

165 sites across 24 countries: United States, Argentina, 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