Conditions: Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 182
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.

Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.

This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.

Detailed description:
The duration of the extension study per participants was 40 weeks broken down as follows:

* 24-week double-blind treatment period,
* 16-week post-treatment elimination follow-up period.

Arms:
arm 1: Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 2: Teriflunomide 7 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 3: Teriflunomide 14 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 4: Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks arm 5: Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks arm 6: Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks

Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Interferon-β [IFN-β] intervention 4: Glatiramer Acetate [GA]
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 intervention 4: Solution in prefilled syringe for subcutaneous injection

Protocol document: