A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Trial ID or NCT#
Status
Purpose
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
Eligibility Criteria
- - 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
- - Primary progressive multiple sclerosis - Disease duration of more than 10 years in patients with EDSS score less than or equal to (
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Contact
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View on ClinicalTrials.gov