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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228163
First Posted: September 28, 2005
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
September 26, 2005
September 28, 2005
March 25, 2015
January 2002
January 2015   (Final data collection date for primary outcome measure)
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 ]
The incidence of adverse events will be measured
Complete list of historical versions of study NCT00228163 on ClinicalTrials.gov Archive Site
  • 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 ]
Assessment of the EDSS scores, MSFC score, Burden of disease and brain atrophy as calculated from MRI scans, annual rate of relpases and quality of life (MSQOL-54 and FIS)
Not Provided
Not Provided
 
Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Sclerosis
Drug: teriflunomide (HMR1726)
tablet, oral administration once daily.
  • Experimental: Teriflunomide 7 mg
    Intervention: Drug: teriflunomide (HMR1726)
  • Experimental: Teriflunomide 14 mg
    Intervention: Drug: teriflunomide (HMR1726)
Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D, Bar-Or A, Traboulsee AL, Reiman LE, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-89. Epub 2012 Feb 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France
 
 
NCT00228163
LTS6048
HMR1726D/2002
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Principal Investigator: Paul W O'Connor, MD St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada
Sanofi
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP