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).

Key facts

Study ID

NCT01412333

Run by

Hoffmann-La Roche

People needed

835

Starts

2011-09-20

Expected to finish

2022-12-30

Last updated by the study team

2024-03-08

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 patients with EDSS score 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 (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

Where it is running

• HonorHealth Neurology — Scottsdale, Arizona, United States
• Territory Neurology and Research Institute — Tucson, Arizona, United States
• Collaborative Neuroscience Research, LLC — Long Beach, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• University of Colorado — Denver, Colorado, United States
• Advanced Neurosciences Research LLC — Fort Collins, Colorado, United States
• Associated Neurologists of Southern CT PC — Fairfield, Connecticut, United States
• Infinity Clinical Research — Hollywood, Florida, United States
• University of Miami; Dept. of Neurology MS Center — Miami, Florida, United States
• Neurological Services of Orlando — Orlando, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Atlanta Neuroscience Institute — Atlanta, Georgia, United States
• Josephson Wallack Munshower Neurology PC — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• MidAmerica Neuroscience Institute — Prairie Village, Kansas, United States
• Associates in Neurology PSC — Lexington, Kentucky, United States
• Dragonfly Research, LLC — Wellesley, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Wayne State University; Department of Neurology — Detroit, Michigan, United States
• The Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• Hope Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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