Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
(CARE-MS II Trial)

Recruiting in Palo Alto (17 mi)

+190 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Genzyme, a Sanofi Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

Research Team

Medical Monitor

Principal Investigator

Genzyme, a Sanofi Company

Eligibility Criteria

Inclusion Criteria

Signed informed consent form (ICF)

Age 18 to 55 years (inclusive) as of the date the ICF was signed

Diagnosis of MS per update of McDonald criteria

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Treatment Details

Interventions

Alemtuzumab (Monoclonal Antibodies)
Interferon beta-1a (Interferons)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Alemtuzumab 24 mgExperimental Treatment1 Intervention

Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.

Group II: Alemtuzumab 12 mgExperimental Treatment1 Intervention

Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.

Group III: Interferon Beta-1aActive Control1 Intervention

Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.