At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
In Brief
A Phase 3 clinical trial evaluating Interferon β-1a and Teriflunomide for Multiple Sclerosis. Completed, enrolled 324 participants across 54 sites in 13 countries.
Detailed Summary
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\]. Secondary objectives were: * To assess the effect of the two doses in comparison to interferon beta-1a on: * Frequency of relapses, * Fatigue, * Participant's satisfaction with treatment. * To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a. The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.
Study Details
Timeline
Interventions
Sterile preservative-free solution packaged in graduated pre-filled syringes Subcutaneous injection Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®
Film-coated tablet Oral administration