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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00228163
First received: September 26, 2005
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Drug: teriflunomide (HMR1726)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2002
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriflunomide 7 mg Drug: teriflunomide (HMR1726)
tablet, oral administration once daily.
Experimental: Teriflunomide 14 mg Drug: teriflunomide (HMR1726)
tablet, oral administration once daily.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228163

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Paul W O'Connor, MD St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00228163     History of Changes
Other Study ID Numbers: LTS6048, HMR1726D/2002
Study First Received: September 26, 2005
Last Updated: March 27, 2012
Health Authority: Canada: Health Canada
France: Ministry of Health

Keywords provided by Sanofi:
Multiple Sclerosis Relapsing Remitting
Secondary Progressive
Progressive Relapsing

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013