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

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

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
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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