Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Remitting Secondary Progressive Progressive Relapsing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1088
Healthy volunteers: no

Brief summary:
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.

Detailed description:
The study period per participant was approximatively 128 weeks broken down as follows:

* Screening period up to 4 weeks,
* 108-week double-blind treatment period (approximatively 2 years)\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.

Arms:
arm 1: Teriflunomide 7 mg once daily for 108 weeks arm 2: Teriflunomide 14 mg once daily for 108 weeks arm 3: Placebo (for teriflunomide) once daily for 108 weeks

Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration

Protocol document: