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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: teriflunomide (HMR1726)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriflunomide 7 mg<br> | Drug: teriflunomide (HMR1726)<br>* tablet, oral administration once daily.<br>|
| Experimental: Teriflunomide 14 mg<br> | Drug: teriflunomide (HMR1726)<br>* tablet, oral administration once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing