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Clinical Trials

Date: 2011-07-11

Type of information: Results

phase: 3

Announcement: results

Company: Sanofi (France) Genzyme (USA - MA)

Product: Lemtrada® (alemtuzumab)

Action mechanism:

This humanized monoclonal antibody targets the cell-surface glycoprotein CD52, which is often expressed on T- and B-lymphocytes. Preliminary research suggests that alemtuzumab depletes the T- and B-cells that may be responsible for the cellular damage in multiple sclerosis, while potentially sparing other cells of the immune system. Early alemtuzumab research has also suggested a distinctive pattern of lymphocyte reconstitution in patients following treatment.

Disease:

multiple sclerosis

Therapeutic area: Autoimmune diseases - Neurodegenerative diseases

Country:

Trial details:

CARE-MS I (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One) was a global, randomized, rater-blinded clinical trial comparing two annual cycles of intravenous alemtuzumab, 12 mg/day for 5 days initially and for 3 days a year later, to three-times weekly subcutaneous interferon beta-1a (Rebif®) in treatment-naïve patients with RRMS. The study enrolled 581 patients who had not previously received treatment to suppress MS, except steroids. The study’s primary outcome measures were reduction in relapse rate and time to sustained accumulation of disability. Secondary outcome measures include: Proportion of patients who are relapse-free at year two; Change from baseline in Expanded Disability Status Scale; Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite; and Percent change from baseline in magnetic*/ resonance imaging (MRI)-T2 hyperintense lesion volume at year two. Additional endpoints included the safety and tolerability of alemtuzumab.

Latest news:

Sanofi and its subsidiary Genzyme have announced positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS). Genzyme is developing alemtuzumab in multiple sclerosis in collaboration with Bayer HealthCare.
In the CARE-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55 percent reduction in relapse rate compared to Rebif® over the two years of the study (p<0.0001), hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success. Statistical significance was not achieved for the second primary endpoint, time to six month sustained accumulation of disability, as compared to Rebif®. At the two year time point, 8 percent of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11 percent of those who received Rebif® (Hazard Ratio=0.70, p=0.22). The patients will have the option to be evaluated over the next 3 years as part of a separate protocol.

Is general: Yes