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 patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : ocrelizumab
  • drug : Rebif placebo
  • drug : ocrelizumab placebo
  • drug : Rebif

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - 55 Years

Inclusion Criteria

- Adult patients, 18-55 years of age inclusive - 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 >/= 30 days prior to both screening and baseline - Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

External Links

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Contact information

Primary Contact:

Clinical Trials Office (650) 498-7061

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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