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):
Intervention(s):
- Drug: Interferon beta-1a
- Drug: Ocrelizumab-matching placebo
- Drug: Ocrelizumab
- Drug: Interferon beta-1a-matching placebo
Phase:
Phase 3
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
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
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