Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
NCT ID: NCT00134563
Last Updated: 2013-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1088 participants
INTERVENTIONAL
2004-09-30
2010-07-31
Brief Summary
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Secondary objectives were:
* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.
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Detailed Description
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* Screening period up to 4 weeks,
* 108-week double-blind treatment period (approximatively 2 years)\*,
* 16-week post-treatment elimination follow-up period.
'\*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Teriflunomide 7 mg
Teriflunomide 7 mg once daily for 108 weeks
Teriflunomide
Film-coated tablet
Oral administration
Teriflunomide 14 mg
Teriflunomide 14 mg once daily for 108 weeks
Teriflunomide
Film-coated tablet
Oral administration
Placebo
Placebo (for teriflunomide) once daily for 108 weeks
Placebo (for teriflunomide)
Film-coated tablet
Oral administration
Interventions
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Teriflunomide
Film-coated tablet
Oral administration
Placebo (for teriflunomide)
Film-coated tablet
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
* Meeting McDonald's criteria for MS diagnosis;
* Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
* No relapse onset in the preceding 60 days prior to randomization;
* Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[ACTH\] or systemic steroid treatment.
Exclusion Criteria
* Significantly impaired bone marrow function;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
18 Years
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Paul O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital (Toronto, Canada)
Locations
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Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis Austria
Vienna, , Austria
sanofi-aventis, Canada
Laval, , Canada
Sanofi-Aventis
Santiago, , Chile
Sanofi-Aventis Administrative Office
Prague, , Czechia
sanofi-aventis Denmark
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Tallinn, , Estonia
sanofi-aventis Finland
Helsinki, , Finland
sanofi-aventis France
Paris, , France
Sanofi-Aventis Deutschland GmbH
Berlin, , Germany
Sanofi-Aventis
Milan, , Italy
Sanofi-Aventis
Gouda, , Netherlands
Sanofi-Aventis
Lysaker, , Norway
sanofi-aventis Poland
Warsaw, , Poland
Sanofi-Aventis
Porto Salvo, , Portugal
Sanofi-Aventis
Moscow, , Russia
Sanofi-Aventis
Bromma, , Sweden
Sanofi-Aventis Switzerland
Geneva, , Switzerland
sanofi-aventis Turkey
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Kiev, , Ukraine
sanofi-aventis UK
Guildford, Surrey, United Kingdom
Countries
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References
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O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.
Sprenger T, Kappos L, Sormani MP, Miller AE, Poole EM, Cavalier S, Wuerfel J. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: Post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022 Oct;28(11):1719-1728. doi: 10.1177/13524585221089534. Epub 2022 Apr 29.
Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
Radue EW, Sprenger T, Gaetano L, Mueller-Lenke N, Cavalier S, Thangavelu K, Panzara MA, Donaldson JE, Woodward FM, Wuerfel J, Wolinsky JS, Kappos L. Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA. Neurol Neuroimmunol Neuroinflamm. 2017 Aug 9;4(5):e390. doi: 10.1212/NXI.0000000000000390. eCollection 2017 Sep.
Sormani MP, Truffinet P, Thangavelu K, Rufi P, Simonson C, De Stefano N. Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e379. doi: 10.1212/NXI.0000000000000379. eCollection 2017 Sep.
Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.
Miller AE, O'Connor P, Wolinsky JS, Confavreux C, Kappos L, Olsson TP, Truffinet P, Wang L, D'Castro L, Comi G, Freedman MS; Teriflunomide Multiple Sclerosis Trial Group. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012 Nov;18(11):1625-32. doi: 10.1177/1352458512450354. Epub 2012 Jun 21.
Other Identifiers
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2004-000555-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HMR1726D/3001
Identifier Type: OTHER
Identifier Source: secondary_id
EFC6049
Identifier Type: -
Identifier Source: org_study_id
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