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
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either in Group A, ocrelizumab 600 milligram (mg) intravenously (IV) every 24 weeks plus Rabif placebo subcutaneously (SC) 3 times weekly, or, in Group B, Rebif 8.8 microgram (mcg) (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) SC 3 times weekly plus ocrelizumab placebo IV 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, providing they fulfill the eligibility criteria.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : ocrelizumab
- drug : Rebif placebo
- drug : ocrelizumab placebo
- drug : Rebif
Phase: Phase 3
Ages Eligible For Study:
- Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010) - At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening) - Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline - Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive