Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
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ClinicalTrials.gov Identifier: NCT00228163 |
Recruitment Status
:
Completed
First Posted
: September 28, 2005
Last Update Posted
: March 25, 2015
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | September 26, 2005 | |||
First Posted Date ICMJE | September 28, 2005 | |||
Last Update Posted Date | March 25, 2015 | |||
Study Start Date ICMJE | January 2002 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE |
The incidence of adverse events will be measured | |||
Change History | Complete list of historical versions of study NCT00228163 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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) | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | |||
Official Title ICMJE | Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | |||
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;
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:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis | |||
Intervention ICMJE | Drug: teriflunomide (HMR1726)
tablet, oral administration once daily. |
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Study Arms |
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Publications * | 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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
147 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | January 2015 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00228163 | |||
Other Study ID Numbers ICMJE | LTS6048 HMR1726D/2002 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sanofi | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |