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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228163
• Other study ID #: LTS6048
• Secondary ID: HMR1726D/2002
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2005
• Last updated: March 24, 2015
• Start date: January 2002
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Canada	Investigational Site Number 16	Calgary
Canada	Investigational Site Number 10	Halifax
Canada	Investigational Site Number 15	London
Canada	Investigational Site Number 11	Montreal
Canada	Investigational Site Number 12	Montreal
Canada	Investigational Site Number 13	Ottawa
Canada	Investigational Site Number 18	Quebec
Canada	Investigational Site Number 14	Toronto
Canada	Investigational Site Number 17	Vancouver
Canada	Investigational Site Number 19	Winnipeg
France	Investigational Site Number 24	Clermont Ferrand Cedex 1
France	Investigational Site Number 21	Lyon Cedex 03
France	Investigational Site Number 30	Marseille Cedex 5
France	Investigational Site Number 23	Montpellier Cedex 5
France	Investigational Site Number 28	Nice Cedex
France	Investigational Site Number 27	Rennes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Annualized relapse rate (number of relapses per patient-year)		528 weeks or until teriflunomide is commercially available in the country where patient lives	No
Secondary	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	No
Secondary	Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score		528 weeks or until teriflunomide is commercially available in the country where patient lives	No
Secondary	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	No
Secondary	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	No
Secondary	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	No