Multiple Sclerosis Clinical Trial

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Summary

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

To assess the effect of the two doses of teriflunomide in comparison to placebo on:

Fatigue;
Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
To evaluate the safety and tolerability of teriflunomide.

View Full Description

Full Description

The study consists of:

A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Relapsing multiple sclerosis,
Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
Pregnant or nursing woman,
Alcohol or drug abuse,
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
Human immunodeficiency virus (HIV) positive,
Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1169

Study ID:

NCT00751881

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 171 Locations for this study

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Sanofi-Aventis Investigational Site Number 840041
Phoenix Arizona, 85060, United States
Sanofi-Aventis Investigational Site Number 840084
Tucson Arizona, 85741, United States
Sanofi-Aventis Investigational Site Number 840008
Loma Linda California, 92354, United States
Sanofi-Aventis Investigational Site Number 840034
Modesto California, 95355, United States
Sanofi-Aventis Investigational Site Number 840090
Fort Collins Colorado, 80528, United States
Sanofi-Aventis Investigational Site Number 840011
Fairfield Connecticut, 06430, United States
Sanofi-Aventis Investigational Site Number 840013
Maitland Florida, 32761, United States
Sanofi-Aventis Investigational Site Number 840083
Ocala Florida, 34474, United States
Sanofi-Aventis Investigational Site Number 840086
Ormond Beach Florida, 32174, United States
Sanofi-Aventis Investigational Site Number 840025
Sarasota Florida, 34239, United States
Sanofi-Aventis Investigational Site Number 840015
St. Petersburg Florida, 33606, United States
Sanofi-Aventis Investigational Site Number 840033
Sunrise Florida, 33351, United States
Sanofi-Aventis Investigational Site Number 840063
Elk Grove Village Illinois, 60007, United States
Sanofi-Aventis Investigational Site Number 840064
Flossmoor Illinois, 60402, United States
Sanofi-Aventis Investigational Site Number 840039
Ft Wayne Indiana, 46804, United States
Sanofi-Aventis Investigational Site Number 840012
Indianapolis Indiana, 46256, United States
Sanofi-Aventis Investigational Site Number 840016
Des Moines Iowa, 50314, United States
Sanofi-Aventis Investigational Site Number 840069
Clinton Township Michigan, 48035, United States
Sanofi-Aventis Investigational Site Number 840075
Grand Rapids Michigan, 49503, United States
Sanofi-Aventis Investigational Site Number 840061
Traverse City Michigan, 49684, United States
Sanofi-Aventis Investigational Site Number 840076
Minneapolis Minnesota, 55455, United States
Sanofi-Aventis Investigational Site Number 840079
Tupelo Mississippi, 38801, United States
Sanofi-Aventis Investigational Site Number 840088
St. Louis Missouri, 63131, United States
Sanofi-Aventis Investigational Site Number 840060
Syracuse New York, 13210, United States
Sanofi-Aventis Investigational Site Number 840029
Charlotte North Carolina, 28204, United States
Sanofi-Aventis Investigational Site Number 840074
Bismarck North Dakota, 58501, United States
Sanofi-Aventis Investigational Site Number 840026
Cincinnati Ohio, 45219, United States
Sanofi-Aventis Investigational Site Number 840078
Dayton Ohio, 45409, United States
Sanofi-Aventis Investigational Site Number 840066
Tulsa Oklahoma, 74137, United States
Sanofi-Aventis Investigational Site Number 840024
Portland Oregon, 97225, United States
Sanofi-Aventis Investigational Site Number 840073
Philadelphia Pennsylvania, 19102, United States
Sanofi-Aventis Investigational Site Number 840022
Philadelphia Pennsylvania, 19107, United States
Sanofi-Aventis Investigational Site Number 840068
Greenville South Carolina, 29615, United States
Sanofi-Aventis Investigational Site Number 840071
Cordova Tennessee, 38018, United States
Sanofi-Aventis Investigational Site Number 840036
Nashville Tennessee, 37232, United States
Sanofi-Aventis Investigational Site Number 840007
San Antonio Texas, 78229, United States
Sanofi-Aventis Investigational Site Number 840006
Bennington Vermont, 05201, United States
Sanofi-Aventis Investigational Site Number 840089
Seattle Washington, 98122, United States
Sanofi-Aventis Investigational Site Number 840020
Charleston West Virginia, 25301, United States
Sanofi-Aventis Investigational Site Number 036005
Bedford Park , 5042, Australia
Sanofi-Aventis Investigational Site Number 036006
Chatswood , 2067, Australia
Sanofi-Aventis Investigational Site Number 036003
Fitzroy , 3065, Australia
Sanofi-Aventis Investigational Site Number 036004
Geelong , 3220, Australia
Sanofi-Aventis Investigational Site Number 036008
Heidelberg , 3084, Australia
Sanofi-Aventis Investigational Site Number 036002
New Lambton , 2305, Australia
Sanofi-Aventis Investigational Site Number 036001
Sydney , 2050, Australia
Sanofi-Aventis Investigational Site Number 040001
Wien , 1010, Austria
Sanofi-Aventis Investigational Site Number 112105
Grodno , , Belarus
Sanofi-Aventis Investigational Site Number 112102
Minsk , 22022, Belarus
Sanofi-Aventis Investigational Site Number 112101
Minsk , , Belarus
Sanofi-Aventis Investigational Site Number 112104
Minsk , , Belarus
Sanofi-Aventis Investigational Site Number 112103
Vitebsk , , Belarus
Sanofi-Aventis Investigational Site Number 056004
Brugge , 8000, Belgium
Sanofi-Aventis Investigational Site Number 056002
Leuven , 3000, Belgium
Sanofi-Aventis Investigational Site Number 056001
Melsbroek , , Belgium
Sanofi-Aventis Investigational Site Number 056003
Sijsele-Damme , , Belgium
Sanofi-Aventis Investigational Site Number 124004
Gatineau , J9J 0, Canada
Sanofi-Aventis Investigational Site Number 124002
Kingston , K7L 2, Canada
Sanofi-Aventis Investigational Site Number 124007
Montreal , H1T 2, Canada
Sanofi-Aventis Investigational Site Number 124008
Ottawa , K2G 6, Canada
Sanofi-Aventis Investigational Site Number 124001
Quebec , G1J 1, Canada
Sanofi-Aventis Investigational Site Number 124003
Regina , S4T 1, Canada
Sanofi-Aventis Investigational Site Number 124006
Saint John , E2L 3, Canada
Sanofi-Aventis Investigational Site Number 152006
Santiago , , Chile
Sanofi-Aventis Investigational Site Number 152007
Santiago , , Chile
Sanofi-Aventis Investigational Site Number 152002
Viña Del Mar , , Chile
Sanofi-Aventis Investigational Site Number 156023
Baotou , 01401, China
Sanofi-Aventis Investigational Site Number 156031
Beijing , 10003, China
Sanofi-Aventis Investigational Site Number 156006
Beijing , 10005, China
Sanofi-Aventis Investigational Site Number 156010
Beijing , 10005, China
Sanofi-Aventis Investigational Site Number 156005
Beijing , 10005, China
Sanofi-Aventis Investigational Site Number 156032
Beijing , 10006, China
Sanofi-Aventis Investigational Site Number 156024
Beijing , 10008, China
Sanofi-Aventis Investigational Site Number 156030
Beijing , 10019, China
Sanofi-Aventis Investigational Site Number 156001
Beijing , 10073, China
Sanofi-Aventis Investigational Site Number 156008
Beijing , 10085, China
Sanofi-Aventis Investigational Site Number 156007
Changchun , 13002, China
Sanofi-Aventis Investigational Site Number 156002
Chengdu , 61004, China
Sanofi-Aventis Investigational Site Number 156025
Guangzhou , 51026, China
Sanofi-Aventis Investigational Site Number 156012
Guangzhou , 51063, China
Sanofi-Aventis Investigational Site Number 156027
Haikou , 57010, China
Sanofi-Aventis Investigational Site Number 156021
Hangzhou , 31001, China
Sanofi-Aventis Investigational Site Number 156033
Jinan , 25003, China
Sanofi-Aventis Investigational Site Number 156034
Nanjing , 21000, China
Sanofi-Aventis Investigational Site Number 156011
Nanjing , 21002, China
Sanofi-Aventis Investigational Site Number 156019
Qingdao , 26600, China
Sanofi-Aventis Investigational Site Number 156029
Shanghai , 20000, China
Sanofi-Aventis Investigational Site Number 156016
Shanghai , 20004, China
Sanofi-Aventis Investigational Site Number 156009
Shenyang , 11000, China
Sanofi-Aventis Investigational Site Number 156022
Shijiazhuang , 05005, China
Sanofi-Aventis Investigational Site Number 156018
Suzhou , 21500, China
Sanofi-Aventis Investigational Site Number 156028
Taiyuan , 03000, China
Sanofi-Aventis Investigational Site Number 156003
Tianjin , 30005, China
Sanofi-Aventis Investigational Site Number 156035
Tianjin , 30021, China
Sanofi-Aventis Investigational Site Number 156017
Wenzhou , 32500, China
Sanofi-Aventis Investigational Site Number 156004
Wuhan , 43003, China
Sanofi-Aventis Investigational Site Number 156014
Xi'An , 71003, China
Sanofi-Aventis Investigational Site Number 156015
Xi'An , 71006, China
Sanofi-Aventis Investigational Site Number 203001
Brno , 65691, Czech Republic
Sanofi-Aventis Investigational Site Number 203002
Ostrava - Poruba , 70852, Czech Republic
Sanofi-Aventis Investigational Site Number 203004
Teplice , 415 2, Czech Republic
Sanofi-Aventis Investigational Site Number 233002
Tallinn , 10617, Estonia
Sanofi-Aventis Investigational Site Number 233001
Tartu , 50406, Estonia
Sanofi-Aventis Investigational Site Number 250005
Besancon , 25030, France
Sanofi-Aventis Investigational Site Number 250008
Dijon Cedex , 21033, France
Sanofi-Aventis Investigational Site Number 250001
Lyon Cedex 03 , 69394, France
Sanofi-Aventis Investigational Site Number 250007
Nantes Cedex 01 , 44093, France
Sanofi-Aventis Investigational Site Number 250006
Nice Cedex , 06002, France
Sanofi-Aventis Investigational Site Number 250002
Nimes , 30029, France
Sanofi-Aventis Investigational Site Number 250003
Poissy , 78300, France
Sanofi-Aventis Investigational Site Number 276010
Bamberg , 96047, Germany
Sanofi-Aventis Investigational Site Number 276003
Bayreuth , 95445, Germany
Sanofi-Aventis Investigational Site Number 276005
Berlin , 10713, Germany
Sanofi-Aventis Investigational Site Number 276001
Erlangen , 91054, Germany
Sanofi-Aventis Investigational Site Number 276006
Gießen , 35385, Germany
Sanofi-Aventis Investigational Site Number 276004
Hannover , 30625, Germany
Sanofi-Aventis Investigational Site Number 276007
Leipzig , 04157, Germany
Sanofi-Aventis Investigational Site Number 276009
Magdeburg , 39120, Germany
Sanofi-Aventis Investigational Site Number 276002
Wiesbaden , 65191, Germany
Sanofi-Aventis Investigational Site Number 300001
Athens , 11527, Greece
Sanofi-Aventis Investigational Site Number 300006
Thessaloniki , 57010, Greece
Sanofi-Aventis Investigational Site Number 484005
Monterrey , 64460, Mexico
Sanofi-Aventis Investigational Site Number 484003
México , 06726, Mexico
Sanofi-Aventis Investigational Site Number 528003
'S Hertogenbosch , 5211 , Netherlands
Sanofi-Aventis Investigational Site Number 528001
Breda , 4818 , Netherlands
Sanofi-Aventis Investigational Site Number 528002
Groesbeek , 6561 , Netherlands
Sanofi-Aventis Investigational Site Number 528004
Nieuwegein , 3435 , Netherlands
Sanofi-Aventis Investigational Site Number 528006
Sittard-Geleen , 6162 , Netherlands
Sanofi-Aventis Investigational Site Number 608004
Cebu City , , Philippines
Sanofi-Aventis Investigational Site Number 608002
Makati City , 1229, Philippines
Sanofi-Aventis Investigational Site Number 608001
Manila , , Philippines
Sanofi-Aventis Investigational Site Number 608003
Quezon City , 1102, Philippines
Sanofi-Aventis Investigational Site Number 616002
Gdansk , 80-80, Poland
Sanofi-Aventis Investigational Site Number 616005
Lodz , 90-54, Poland
Sanofi-Aventis Investigational Site Number 616001
Lublin , 20-71, Poland
Sanofi-Aventis Investigational Site Number 616004
Szczecin , 70-21, Poland
Sanofi-Aventis Investigational Site Number 616003
Warszawa 44 , 04-14, Poland
Sanofi-Aventis Investigational Site Number 642006
Bacau , 60011, Romania
Sanofi-Aventis Investigational Site Number 642005
Brasov , 50012, Romania
Sanofi-Aventis Investigational Site Number 642001
Bucuresti , 01058, Romania
Sanofi-Aventis Investigational Site Number 642007
Oradea , 41015, Romania
Sanofi-Aventis Investigational Site Number 703003
Bratislava 2 , 82606, Slovakia
Sanofi-Aventis Investigational Site Number 703005
Bratislava 2 , 82606, Slovakia
Sanofi-Aventis Investigational Site Number 703001
Martin , 03659, Slovakia
Sanofi-Aventis Investigational Site Number 703006
Presov , 08181, Slovakia
Sanofi-Aventis Investigational Site Number 724001
Barcelona , 08035, Spain
Sanofi-Aventis Investigational Site Number 724007
Getafe , 28905, Spain
Sanofi-Aventis Investigational Site Number 724002
Girona , 17007, Spain
Sanofi-Aventis Investigational Site Number 724004
Madrid , 28040, Spain
Sanofi-Aventis Investigational Site Number 724003
Sevilla , 41071, Spain
Sanofi-Aventis Investigational Site Number 752002
Stockholm , 141 8, Sweden
Sanofi-Aventis Investigational Site Number 752001
Stockholm , 171 7, Sweden
Sanofi-Aventis Investigational Site Number 752003
Stockholm , 182 8, Sweden
Sanofi-Aventis Investigational Site Number 764002
Bangkok-Noi , 10700, Thailand
Sanofi-Aventis Investigational Site Number 764001
Bangkok , 10330, Thailand
Sanofi-Aventis Investigational Site Number 788003
Manouba , 2010, Tunisia
Sanofi-Aventis Investigational Site Number 788004
Sfax , 3029, Tunisia
Sanofi-Aventis Investigational Site Number 788002
Tunis , 1006, Tunisia
Sanofi-Aventis Investigational Site Number 788001
Tunis , 1007, Tunisia
Sanofi-Aventis Investigational Site Number 792011
Edirne , , Turkey
Sanofi-Aventis Investigational Site Number 792009
Istanbul , 34147, Turkey
Sanofi-Aventis Investigational Site Number 792001
Istanbul , 34390, Turkey
Sanofi-Aventis Investigational Site Number 792007
Istanbul , , Turkey
Sanofi-Aventis Investigational Site Number 792010
Istanbul , , Turkey
Sanofi-Aventis Investigational Site Number 792012
Izmir , 35380, Turkey
Sanofi-Aventis Investigational Site Number 792002
Kocaeli , 41380, Turkey
Sanofi-Aventis Investigational Site Number 792003
Manisa , , Turkey
Sanofi-Aventis Investigational Site Number 792005
Samsun , , Turkey
Sanofi-Aventis Investigational Site Number 792004
Trabzon , 61080, Turkey
Sanofi-Aventis Investigational Site Number 804101
Chernihiv , 14025, Ukraine
Sanofi-Aventis Investigational Site Number 804103
Dnipropetrovsk , 49027, Ukraine
Sanofi-Aventis Investigational Site Number 804107
Donetsk , 83003, Ukraine
Sanofi-Aventis Investigational Site Number 804117
Donetsk , 83099, Ukraine
Sanofi-Aventis Investigational Site Number 804119
Ivano-Frankovsk , 76008, Ukraine
Sanofi-Aventis Investigational Site Number 804102
Kharkiv , 61018, Ukraine
Sanofi-Aventis Investigational Site Number 804109
Kharkov , 61068, Ukraine
Sanofi-Aventis Investigational Site Number 804115
Kiev , 04050, Ukraine
Sanofi-Aventis Investigational Site Number 804116
Kiev , 04112, Ukraine
Sanofi-Aventis Investigational Site Number 804108
Kiev , , Ukraine
Sanofi-Aventis Investigational Site Number 804111
Lutsk , 43005, Ukraine
Sanofi-Aventis Investigational Site Number 804124
Lutsk , 43024, Ukraine
Sanofi-Aventis Investigational Site Number 804114
Lviv , 79010, Ukraine
Sanofi-Aventis Investigational Site Number 804121
Lviv , 79010, Ukraine
Sanofi-Aventis Investigational Site Number 804120
Poltava , 36011, Ukraine
Sanofi-Aventis Investigational Site Number 804105
Vinnytsya , 21005, Ukraine
Sanofi-Aventis Investigational Site Number 804118
Zaporizhya , 69035, Ukraine
Sanofi-Aventis Investigational Site Number 804104
Zaporizhzhia , 69600, Ukraine
Sanofi-Aventis Investigational Site Number 804122
Zaporozhye , 69000, Ukraine
Sanofi-Aventis Investigational Site Number 826002
Edinburgh , EH4 2, United Kingdom
Sanofi-Aventis Investigational Site Number 826004
Haywards Heath , RH16 , United Kingdom
Sanofi-Aventis Investigational Site Number 826001
Irvine , KA12 , United Kingdom
Sanofi-Aventis Investigational Site Number 826003
Leeds , LS1 3, United Kingdom
Sanofi-Aventis Investigational Site Number 826005
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1169

Study ID:

NCT00751881

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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