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 (\
Contact us to find out if this trial is right for you.
Contact
Clinical Trials Office
(650) 498-7061
View on ClinicalTrials.gov