Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing
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.
Interventions
tablet, oral administration once daily.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score | 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 |
| 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 |
Countries
Canada, France
Outcome results
None listed