An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis (TOWER)

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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
Study Start Date: August 2008
Actual Primary Completion Date: April 2012
Actual Study Completion Date: August 2015

Arm:
- Experimental: Teriflunomide 7 mg / 14 mg
- Experimental: Teriflunomide 14 mg / 14 mg
- Placebo Comparator: Placebo / Teriflunomide 14 mg


Related journal:
- Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study.