Conditions: Multiple Sclerosis
Keywords: MS glatiramer acetate adjunctive therapy relapses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].

The secondary objectives were:

* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

Detailed description:
The duration of the study period for a participant was approximatively 44 weeks broken down as follows:

* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Arms:
arm 1: Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 2: Teriflunomide 7 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 3: Teriflunomide 14 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks

Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Glatiramer Acetate (GA)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Solution in prefilled syringe for subcutaneous injection

Protocol document: