Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: teriflunomide (HMR1726)

• Registration Number: NCT00228163
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

Detailed Description

Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;

* subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.

* subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.

The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:

* Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,

* Post-washout follow-up: 4 weeks after last treatment intake.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Satisfactorily completion of HMR1726D/2001 study with respect to safety.
• If female subject, non-childbearing potential or child bearing potential with adequate contraception.
• Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
• Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
• Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
• Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
• Willingness to participate in a long-term safety and efficacy trial.

Exclusion Criteria

• Subject who did not complete HMR 1726D/2001 study for safety reasons.
• Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
• Pregnancy.
• Breast-feeding.
• Wish to parent.
• Likelihood of requiring treatment during the study period with drugs not permitted.
• Disallowed therapies such asw immunomodulators, immunosuppressants.
• Recent history of drug or alcohol abuse.
• Liver function impairment.
• Abnormal mental conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teriflunomide 7 mg	teriflunomide (HMR1726)	-
Teriflunomide 14 mg	teriflunomide (HMR1726)	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives

Secondary Outcome Measures

Name	Time	Method
Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI)	528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)	528 weeks or until teriflunomide is commercially available in the country where patient lives
Annualized relapse rate (number of relapses per patient-year)	528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score	528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score	528 weeks or until teriflunomide is commercially available in the country where patient lives
Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score	528 weeks or until teriflunomide is commercially available in the country where patient lives

Trial Locations

Locations (16)

Investigational Site Number 12; 🇨🇦 Montreal, Canada

Investigational Site Number 11; 🇨🇦 Montreal, Canada

Investigational Site Number 17; 🇨🇦 Vancouver, Canada

Investigational Site Number 19; 🇨🇦 Winnipeg, Canada

Investigational Site Number 23; 🇫🇷 Montpellier Cedex 5, France

Investigational Site Number 14; 🇨🇦 Toronto, Canada

Investigational Site Number 30; 🇫🇷 Marseille Cedex 5, France

Investigational Site Number 28; 🇫🇷 Nice Cedex, France

Investigational Site Number 13; 🇨🇦 Ottawa, Canada

Investigational Site Number 18; 🇨🇦 Quebec, Canada

Investigational Site Number 21; 🇫🇷 Lyon Cedex 03, France

Investigational Site Number 16; 🇨🇦 Calgary, Canada

Investigational Site Number 10; 🇨🇦 Halifax, Canada

Investigational Site Number 15; 🇨🇦 London, Canada

Investigational Site Number 24; 🇫🇷 Clermont Ferrand Cedex 1, France

Investigational Site Number 27; 🇫🇷 Rennes Cedex, France