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
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 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.
Inclusion Criteria:
Exclusion Criteria:
Philadelphia, Pennsylvania 19141, United States
Tacoma, Washington 98405, United States
Ciudad Autonoma Bs As, C1209AAB, Argentina
Sofia, 1407, Bulgaria
Hanover, 30171, Germany
Rostock, 18147, Germany
Gallarate, Aosta Valley 21013, Italy
Riga, 1015, Latvia
Monterrey, Nuevo León 64460, Mexico
Gdansk, 80-803, Poland
Moskva, Moscow Oblast 107150, Russia
Moskva, Moscow Oblast 115682, Russia
Saint Petersburg, Sankt-Peterburg 194044, Russia
Saint Petersburg, Sankt-Peterburg 194354, Russia
Bratislava, 851 07, Slovakia
Santa Cruz de Tenerife, Tenerife 38010, Spain
Mannouba, 2010, Tunisia
Donetsk, 83099, Ukraine
Kharkiv, 61068, Ukraine
Vinnytsia, 21005, Ukraine
Liverpool, L9 7LJ, United Kingdom