Conditions: Multiple Sclerosis
Keywords: MS interferon-beta adjunctive therapy relapses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
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 with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].

Secondary objectives were:

* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β 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 IFN-β.

Detailed description:
The study period per 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: Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 2: Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 3: Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks

Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for Teriflunomide) intervention 3: Interferon-β
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection

Protocol document: