A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
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.