Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment teriflunomide (hmr1726)
Phase phase 3
Sponsor Sanofi
Start date October 2006
End date December 2015
Trial size 1080 participants
Trial identifier NCT00803049, 2006-003361-14, LTS6050

Summary

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse.

The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
teriflunomide (hmr1726)
Tablet, oral administration once daily.
(Experimental)
teriflunomide (hmr1726)
Tablet, oral administration once daily.

Primary Outcomes

Measure
Number of patients with adverse events
time frame: Up to a maximum of 292 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives

Secondary Outcomes

Measure
Time to disability progression as assessed by Expanded Disability Status Scale (EDSS)
time frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives
Proportion of patients free of disability progression
time frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives
Annualized relapse rate (number of confirmed relapses per patient-year)
time frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives
Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI
time frame: Up to a maximum of 288 weeks

Eligibility Criteria

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

Inclusion Criteria: - Patient who has completed the previous double-blind placebo-controlled study EFC6049 and who does not meet criteria for treatment withdrawal. - Willingness to participate in a long-term safety/efficacy trial. Exclusion Criteria: - 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 Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses
Description Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue in the extension study; - patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose of teriflunomide. - patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg. The study period per patient is broken down as follows: - Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives, - Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if patient continues on teriflunomide treatment by obtaining it's commercial form after end of the study. The total duration of the extension is 292 weeks (about 6 years) from the first patient enrolled or until teriflunomide is commercially available in the country where patient lives.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sanofi.