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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

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

  • Drug: teriflunomide (HMR1726)
    • tablet, oral administration once daily.

Arms, Groups and Cohorts

  • Experimental: Teriflunomide 7 mg
  • Experimental: Teriflunomide 14 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Annualized relapse rate (number of relapses per patient-year)
    • Time Frame: 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
    • Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives
  • Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul W O’Connor, MD, Principal Investigator, St. Michael’s Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada

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