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

Sanofi147 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Multiple Sclerosis

Interventions

teriflunomide (HMR1726)DRUG

tablet, oral administration once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (16)

Investigational Site Number 16

Calgary, Canada

Investigational Site Number 10

Halifax, Canada

Investigational Site Number 15

London, Canada

Outcomes

Primary Outcomes

Number of patients with adverse events

Time frame: 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