A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT01412333
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2023-03-03
Brief 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).
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: Interferon beta-1a
Drug: Ocrelizumab-matching placebo
Drug: Ocrelizumab
Drug: Interferon beta-1a-matching placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2011-09-20 |
| Primary Completion (Actual) | 2015-05-12 |
| Study Completion | 2022-12-30 |
| Enrollment (Actual) | 835 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | WA21093 2010-020315-36 (EudraCT Number) |