The CARE-MS I trial (comparison of alemtuzumab and Rebif efficacy in multiple sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.
Initiation of this Phase III program follows the successful completion of the initial treatment period in the Phase II trial. Interim results from the Phase II trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months. Results of the primary outcomes from this trial at 36 months are expected to be presented on October 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, in Prague.
The CARE-MS I study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe, and will again compare alemtuzumab-treated patients to Rebif-treated patients according to two co-primary endpoints: the time to sustained accumulation of disability, and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for five days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for three days. All patients will be followed from their entry into the trial until two years from the date that the last patient is randomized to treatment.