PER-024-14
Completed
未知
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
F. Hoffmann- La Roche, Ltd /Genentech Inc,0 sites21 target enrollmentAugust 8, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F. Hoffmann- La Roche, Ltd /Genentech Inc,
- Enrollment
- 21
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The inclusion criteria are the following:
- •1\.Ability to provide written, informed consent and be able to follow the schedule of protocol assessments \*.
- •2\.Ages 18\-55 years at screening, inclusive.
- •3\.Diagnosis of MS, in accordance with the revised McDonald criteria (2010\).
- •4\.At least 2 documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening (but not within 30 days prior to screening).
- •5\.Neurological stability for 30 days prior to both screening and baseline.
- •6\.EDSS, at screening, from 0 to 5\.5 inclusive.
- •7\.Documented MRI of brain with abnormalities consistent with MS prior to screening.
- •8\.Patients of reproductive potential must use reliable means of contraception as described below as a minimum (adherence to local requirements, if more stringent, is required\*\*):
- •For female patients: Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B\-cells have repleted, whichever is longer.
Exclusion Criteria
- •Primary progressive multiple sclerosis
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Chronic treatment with systemic corticosteroids or immunosuppressants, chronic immune system diseases or other conditions that may rule out the involvement of the patient in the study.
- •History of progressive multifocal leukoencephalopathy
- •Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis)
- •Known presence of other neurological disorders which may mimic multiple sclerosis
- •History of or currently active primary or secondary immunodeficiency
- •Pregnancy or lactation
- •Contraindications to or intolerance of oral or I.V. corticosteroids
- •Contraindication to or intolerance of interferon beta\-1a (Rebif
Outcomes
Primary Outcomes
Not specified
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