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Sponsor: Hoffmann-La Roche
Conditions: Relapsing Multiple Sclerosis
Interventions: Interferon beta-1a, Ocrelizumab-matching placebo, Ocrelizumab, Interferon beta-1a-matching placebo
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile
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.
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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 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
- Phoenix, Arizona, United States
- Carmichael, California, United States
- La Jolla, California, United States
- Laguna Hills, California, United States
- Los Angeles, California, United States
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- San Francisco, California, United States
- Melbourne, Florida, United States
- Miami, Florida, United States
- South Miami, Florida, United States
- Tampa, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Northbrook, Illinois, United States
- Avon, Indiana, United States
- Boston, Massachusetts, United States
- Clinton Township, Michigan, United States
- Farmington Hills, Michigan, United States
- Golden Valley, Minnesota, United States
- St Louis, Missouri, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- Advance, North Carolina, United States
- Charlotte, North Carolina, United States
- Charlotte, North Carolina, United States
- Hickory, North Carolina, United States
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