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

Not Recruiting

Trial ID: NCT01412333

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


Inclusion 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

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
   antibodies

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

   - History of progressive multifocal leukoencephalopathy

   - Contraindications to or intolerance of oral or IV corticosteroids

   - Contraindications to Rebif or incompatibility with Rebif use

Intervention(s):

drug: ocrelizumab

drug: Interferon beta-1a

drug: Ocrelizumab-matching placebo

drug: Interferon beta-1a-matching placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Clinical Trials Office
(650) 498-7061