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