Trial Search Results

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants 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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):


  • Drug: Interferon beta-1a
  • Drug: Ocrelizumab-matching placebo
  • Drug: Ocrelizumab
  • Drug: Interferon beta-1a-matching placebo


Phase 3


Inclusion Criteria:

   - Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria

   - 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

   - 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

Exclusion Criteria:

   - Primary progressive multiple sclerosis

   - Disease duration of more than 10 years in patients with EDSS score less than or equal
   to (
   - Contraindications for MRI

   - Known presence of other neurological disorders which may mimic multiple sclerosis

   - Pregnancy or lactation

   - Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
   during the course of the study

   - History of or currently active primary or secondary immunodeficiency

   - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal

   - Active infection, or history of or known presence of recurrent or chronic infection
   (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis,

   - History of progressive multifocal leukoencephalopathy

   - Contraindications to or intolerance of oral or IV corticosteroids

   - Contraindications to Rebif or incompatibility with Rebif use

Ages Eligible for Study

18 Years - 55 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Clinical Trials Office
(650) 498-7061
Not Recruiting