Conditions: Multiple Sclerosis
Keywords: relapsing multiple sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1169
Healthy volunteers: no

Brief summary:
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.

Detailed description:
The study consists of:

* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

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

Arms:
arm 1: Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily. arm 2: Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily. arm 3: Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Interventions: intervention 1: Placebo intervention 2: Teriflunomide
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration

Protocol document: