Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments placebo (for teriflunomide), teriflunomide
Phase phase 3
Sponsor Sanofi
Start date August 2008
End date April 2012
Trial size 1169 participants
Trial identifier NCT00751881, 2007-004452-36, EFC10531

Summary

The primary objective of the study is to assess the effect of two doses of Teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in patients with relapsing MS.

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

Other secondary objectives are:

- 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 patient's health on his or her overall well being.

- To evaluate the safety and tolerability of teriflunomide.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Teriflunomide 7 mg once daily for 48 to 152 weeks depending on time of enrollment (core treatment period), then optional, Teriflunomide 14 mg once daily until teriflunomide is commercially available in the country the participant lives (extension treatment period).
teriflunomide HMR1726
Film-coated tablet Oral administration
(Experimental)
Teriflunomide 14 mg once daily for 48 to 152 weeks depending on time of enrollment (core treatment period), then optional, Teriflunomide 14 mg once daily until teriflunomide is commercially available in the country the participant lives (extension treatment period).
teriflunomide HMR1726
Film-coated tablet Oral administration
(Placebo Comparator)
Placebo (for teriflunomide) once daily for 48 to 152 weeks depending on time of enrollment (core treatment period), then optional, Teriflunomide 14 mg once daily until teriflunomide is commercially available in the country the participant lives (extension treatment period).
placebo (for teriflunomide)
Film-coated tablet Oral administration
teriflunomide HMR1726
Film-coated tablet Oral administration

Primary Outcomes

Measure
Annualized Relapse Rate (ARR): Poisson Regression Estimate
time frame: Core treatment period between 48 - 152 weeks depending on time of enrollment

Secondary Outcomes

Measure
Time to Disability Progression
time frame: Core treatment period between 48 - 152 weeks depending on time of enrollment
Time Without Relapse
time frame: Core treatment period between 48 - 152 weeks depending on time of enrollment
Change From Baseline to Week 48 in EDSS Total Score
time frame: Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48
Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score
time frame: Baseline (before randomization), Week 12, Week 24 and Week 48
Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score
time frame: Baseline (before randomization) and up to Week 152
Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores
time frame: Baseline (before randomization), Week 12, Week 24 and Week 48
Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores
time frame: Baseline (before randomization) and up to Week 152
Overview of Adverse Events
time frame: From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Relapsing multiple sclerosis, - Two relapses in prior 2 years or one relapse in prior year. Exclusion Criteria: - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease, - Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia, - Pregnant or nursing woman, - Alcohol or drug abuse, - Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate, - Human immunodeficiency virus (HIV) positive, - Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

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
Description The study consists in: - A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo is administered in double-blind fashion until a fixed common end date which is approximately 48 weeks after randomization of the last participant. - An extension treatment period: the highest dose of teriflunomide is administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue. The overall treatment period is followed by a 4-week elimination follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Sanofi.