Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Subjects with relapsing remitting multiple sclerosis
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 180
Healthy volunteers: no

Brief summary:
General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Rebif® New Formulation (IFN-beta-1a, RNF) intervention 2: Placebo intervention 3: Rebif® New Formulation (IFN-beta-1a, RNF)
Intervention descriptions: intervention 1: RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks. intervention 2: Matching placebo will be administered subcutaneously three times a week for 16 weeks. intervention 3: RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.

Protocol document: