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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: teriflunomide (HMR1726)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228163

HMR1726D/2002

LTS6048

Details and patient eligibility

About

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.

Full 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.

Enrollment

147 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.