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

Completed · Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

Key facts

Study ID

NCT01247324

Run by

Hoffmann-La Roche

People needed

821

Starts

2011-08-31

Expected to finish

2022-12-31

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Primary progressive multiple sclerosis
• Disease duration of more than 10 years in participants with EDSS less than or equal to (<=) 2.0 at screening
• 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 (e.g., 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

Where it is running

• Mercy Medical Group — Carmichael, California, United States
• Scripps Clinic — La Jolla, California, United States
• MS Center of California — Laguna Hills, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Neuro-Therapeutics Inc. — Pasadena, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Health First Physicians Inc. — Melbourne, Florida, United States
• Mercy Research Institute — Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Shepherd Center Inc. — Atlanta, Georgia, United States
• Emory University; Department of Neurology — Atlanta, Georgia, United States
• NeuroTrials Research, Inc. — Atlanta, Georgia, United States
• Northwestern University; Dept. of Neurology — Chicago, Illinois, United States
• Consultants in Neurology Ltd — Northbrook, Illinois, United States
• American Health Network Institute, LLC — Avon, Indiana, United States
• Massachusetts General Hospital. — Boston, Massachusetts, United States
• Michigan Neurology Associates P.C. — Clinton Township, Michigan, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• The Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
• Washington University; Wash Uni. Sch. Of Med — St Louis, Missouri, United States
• The MS Center for Innovations In Care — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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