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Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two


Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV [Low]- and High-Dose Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy




The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by magnetic resonance imaging (MRI). Patients will have monthly laboratory tests and comprehensive testing every 3 months.

Study Status: Completed


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Biological: alemtuzumab
Biological: alemtuzumab
Biological: interferon beta-1a (Rebif®)
Phase 3

Verified by Genzyme November, 2012

Sponsored by: Genzyme
Information provided by: Genzyme identifier: NCT00548405

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

The Cleveland Clinic Mellen Center
Cleveland, Ohio
United States

Medical Monitor., Study Director

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