At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Rebif® New Formulation (IFN-beta-1a, RNF) and Placebo for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 180 participants.
Detailed 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.
Study Details
Timeline
Interventions
RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.
Matching placebo will be administered subcutaneously three times a week for 16 weeks.
RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.