Conditions: Multiple Sclerosis
Keywords: Relapsing-remitting multiple sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 324
Healthy volunteers: no

Brief 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.

Detailed description:
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label.

The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study.

The overall treatment period was followed by a 4-week elimination follow-up period.

Arms:
arm 1: Teriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). arm 2: Teriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period). arm 3: Interferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period).

Interventions: intervention 1: Interferon β-1a intervention 2: Teriflunomide
Intervention descriptions: intervention 1: 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® intervention 2: Film-coated tablet

Oral administration

Protocol document: