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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

teriflunomide (HMR1726)

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Teriflunomide 7 mg

Teriflunomide 14 mg

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Secondary Outcome Measures

Annualized relapse rate (number of relapses per patient-year)

Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score

Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score

Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI)

Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score

Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)

Full Information

NCT ID

NCT00228163

First Posted

September 26, 2005

Last Updated

March 24, 2015

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00228163

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

January 2002 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis Relapsing Remitting, Secondary Progressive, Progressive Relapsing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriflunomide 7 mg

Arm Type

Experimental

Arm Title

Teriflunomide 14 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

teriflunomide (HMR1726)

Intervention Description

tablet, oral administration once daily.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Annualized relapse rate (number of relapses per patient-year)

Time Frame