A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy

INTERVENTION: Trade Name: MabCampath ® Pharmaceutical Form: Solution for infusion INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Rebif Pharmaceutical Form: Solution for injection INN or Proposed INN: INTERFERON BETA‐1A Other descriptive name: INTERFERON BETA‐1A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 44‐ CONDITION: Relapsing Remitting Multiple Sclerosis ; MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: 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).; The main objective of this study is to establish the efficacy of two; different doses of alemtuzumab as a treatment for relapsing remitting; multiple sclerosis (MS), in comparison with Rebif® (interferon beta‐1a). Primary end point(s): •Time to Sustained Accumulation of Disability (SAD); •Relapse Rate Secondary Objective: To establish the safety of two different doses of alemtuzumab as a; treatment for relapsing‐remitting multiple sclerosis (MS), in comparison; with Rebif® (interferon beta‐1a). Timepoint(s) of evaluation of this end point: 24 Months SECONDARY OUTCOME: Secondary end point(s): •Proportion of patients who are relapse free at Year 2 ; •Change from baseline in EDSS (Expanded Disability Status Scale) ; •Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) ; •Percent change from baseline in MRI‐T2 hyperintense lesion volume at ; Year 2 Timepoint(s) of evaluation of this end point: 24 Months INCLUSION CRITERIA: •Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS •Onset of MS symptoms within 10 years •EDSS score 0.0 to 5.0 •=2 MS attacks within 24 months, with =1 attack within 12 months •=1 MS attack (relapse)during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 840 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0