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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00751881
Other study ID # EFC10531
Secondary ID 2007-004452-36
Status Completed
Phase Phase 3
First received May 7, 2008
Last updated August 26, 2015
Start date August 2008
Est. completion date August 2015

Study information

Verified date August 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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

Other secondary objectives are:

- 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 patient's health on his or her overall well being.

- To evaluate the safety and tolerability of teriflunomide.


Description:

The study consists in:

- A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo is administered in double-blind fashion until a fixed common end date which is approximately 48 weeks after randomization of the last participant.

- An extension treatment period: the highest dose of teriflunomide is administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

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


Recruitment information / eligibility

Status Completed
Enrollment 1169
Est. completion date August 2015
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo (for teriflunomide)
Film-coated tablet Oral administration
Teriflunomide
Film-coated tablet Oral administration

Locations

Country Name City State
Australia Sanofi-Aventis Investigational Site Number 036005 Bedford Park
Australia Sanofi-Aventis Investigational Site Number 036006 Chatswood
Australia Sanofi-Aventis Investigational Site Number 036003 Fitzroy
Australia Sanofi-Aventis Investigational Site Number 036004 Geelong
Australia Sanofi-Aventis Investigational Site Number 036008 Heidelberg
Australia Sanofi-Aventis Investigational Site Number 036002 New Lambton
Australia Sanofi-Aventis Investigational Site Number 036001 Sydney
Austria Sanofi-Aventis Investigational Site Number 040001 Wien
Belarus Sanofi-Aventis Investigational Site Number 112105 Grodno
Belarus Sanofi-Aventis Investigational Site Number 112101 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112102 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112104 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112103 Vitebsk
Belgium Sanofi-Aventis Investigational Site Number 056004 Brugge
Belgium Sanofi-Aventis Investigational Site Number 056002 Leuven
Belgium Sanofi-Aventis Investigational Site Number 056001 Melsbroek
Belgium Sanofi-Aventis Investigational Site Number 056003 Sijsele-Damme
Canada Sanofi-Aventis Investigational Site Number 124004 Gatineau
Canada Sanofi-Aventis Investigational Site Number 124002 Kingston
Canada Sanofi-Aventis Investigational Site Number 124007 Montreal
Canada Sanofi-Aventis Investigational Site Number 124008 Ottawa
Canada Sanofi-Aventis Investigational Site Number 124001 Quebec
Canada Sanofi-Aventis Investigational Site Number 124003 Regina
Canada Sanofi-Aventis Investigational Site Number 124006 Saint John
Chile 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
China Sanofi-Aventis Investigational Site Number 156023 Baotou
China Sanofi-Aventis Investigational Site Number 156001 Beijing
China Sanofi-Aventis Investigational Site Number 156005 Beijing
China Sanofi-Aventis Investigational Site Number 156006 Beijing
China Sanofi-Aventis Investigational Site Number 156008 Beijing
China Sanofi-Aventis Investigational Site Number 156010 Beijing
China Sanofi-Aventis Investigational Site Number 156024 Beijing
China Sanofi-Aventis Investigational Site Number 156030 Beijing
China Sanofi-Aventis Investigational Site Number 156031 Beijing
China Sanofi-Aventis Investigational Site Number 156032 Beijing
China Sanofi-Aventis Investigational Site Number 156007 Changchun
China Sanofi-Aventis Investigational Site Number 156002 Chengdu
China Sanofi-Aventis Investigational Site Number 156012 Guangzhou
China Sanofi-Aventis Investigational Site Number 156025 Guangzhou
China Sanofi-Aventis Investigational Site Number 156027 Haikou
China Sanofi-Aventis Investigational Site Number 156021 Hangzhou
China Sanofi-Aventis Investigational Site Number 156033 Jinan
China Sanofi-Aventis Investigational Site Number 156011 Nanjing
China Sanofi-Aventis Investigational Site Number 156034 Nanjing
China Sanofi-Aventis Investigational Site Number 156019 Qingdao
China Sanofi-Aventis Investigational Site Number 156016 Shanghai
China Sanofi-Aventis Investigational Site Number 156029 Shanghai
China Sanofi-Aventis Investigational Site Number 156009 Shenyang
China Sanofi-Aventis Investigational Site Number 156022 Shijiazhuang
China Sanofi-Aventis Investigational Site Number 156018 Suzhou
China Sanofi-Aventis Investigational Site Number 156028 Taiyuan
China Sanofi-Aventis Investigational Site Number 156003 Tianjin
China Sanofi-Aventis Investigational Site Number 156035 Tianjin
China Sanofi-Aventis Investigational Site Number 156017 Wenzhou
China Sanofi-Aventis Investigational Site Number 156004 Wuhan
China Sanofi-Aventis Investigational Site Number 156014 Xi'An
China Sanofi-Aventis Investigational Site Number 156015 Xi'An
Czech Republic Sanofi-Aventis Investigational Site Number 203001 Brno
Czech Republic Sanofi-Aventis Investigational Site Number 203002 Ostrava - Poruba
Czech Republic Sanofi-Aventis Investigational Site Number 203004 Teplice
Estonia Sanofi-Aventis Investigational Site Number 233002 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233001 Tartu
France Sanofi-Aventis Investigational Site Number 250005 Besancon
France Sanofi-Aventis Investigational Site Number 250008 Dijon Cedex
France Sanofi-Aventis Investigational Site Number 250001 Lyon Cedex 03
France Sanofi-Aventis Investigational Site Number 250007 Nantes Cedex 01
France Sanofi-Aventis Investigational Site Number 250006 Nice Cedex
France Sanofi-Aventis Investigational Site Number 250002 Nimes
France Sanofi-Aventis Investigational Site Number 250003 Poissy
Germany Sanofi-Aventis Investigational Site Number 276010 Bamberg
Germany Sanofi-Aventis Investigational Site Number 276003 Bayreuth
Germany Sanofi-Aventis Investigational Site Number 276005 Berlin
Germany Sanofi-Aventis Investigational Site Number 276001 Erlangen
Germany Sanofi-Aventis Investigational Site Number 276006 Gießen
Germany Sanofi-Aventis Investigational Site Number 276004 Hannover
Germany Sanofi-Aventis Investigational Site Number 276007 Leipzig
Germany Sanofi-Aventis Investigational Site Number 276009 Magdeburg
Germany Sanofi-Aventis Investigational Site Number 276002 Wiesbaden
Greece Sanofi-Aventis Investigational Site Number 300001 Athens
Greece Sanofi-Aventis Investigational Site Number 300006 Thessaloniki
Mexico Sanofi-Aventis Investigational Site Number 484003 México
Mexico Sanofi-Aventis Investigational Site Number 484005 Monterrey
Netherlands Sanofi-Aventis Investigational Site Number 528003 'S Hertogenbosch
Netherlands Sanofi-Aventis Investigational Site Number 528001 Breda
Netherlands Sanofi-Aventis Investigational Site Number 528002 Groesbeek
Netherlands Sanofi-Aventis Investigational Site Number 528004 Nieuwegein
Netherlands Sanofi-Aventis Investigational Site Number 528006 Sittard-Geleen
Philippines Sanofi-Aventis Investigational Site Number 608004 Cebu City
Philippines Sanofi-Aventis Investigational Site Number 608002 Makati City
Philippines Sanofi-Aventis Investigational Site Number 608001 Manila
Philippines Sanofi-Aventis Investigational Site Number 608003 Quezon City
Poland Sanofi-Aventis Investigational Site Number 616002 Gdansk
Poland Sanofi-Aventis Investigational Site Number 616005 Lodz
Poland Sanofi-Aventis Investigational Site Number 616001 Lublin
Poland Sanofi-Aventis Investigational Site Number 616004 Szczecin
Poland Sanofi-Aventis Investigational Site Number 616003 Warszawa 44
Romania Sanofi-Aventis Investigational Site Number 642006 Bacau
Romania Sanofi-Aventis Investigational Site Number 642005 Brasov
Romania Sanofi-Aventis Investigational Site Number 642001 Bucuresti
Romania Sanofi-Aventis Investigational Site Number 642007 Oradea
Slovakia Sanofi-Aventis Investigational Site Number 703003 Bratislava 2
Slovakia Sanofi-Aventis Investigational Site Number 703005 Bratislava 2
Slovakia Sanofi-Aventis Investigational Site Number 703001 Martin
Slovakia Sanofi-Aventis Investigational Site Number 703006 Presov
Spain Sanofi-Aventis Investigational Site Number 724001 Barcelona
Spain Sanofi-Aventis Investigational Site Number 724007 Getafe
Spain Sanofi-Aventis Investigational Site Number 724002 Girona
Spain Sanofi-Aventis Investigational Site Number 724004 Madrid
Spain Sanofi-Aventis Investigational Site Number 724003 Sevilla
Sweden Sanofi-Aventis Investigational Site Number 752001 Stockholm
Sweden Sanofi-Aventis Investigational Site Number 752002 Stockholm
Sweden Sanofi-Aventis Investigational Site Number 752003 Stockholm
Thailand Sanofi-Aventis Investigational Site Number 764001 Bangkok
Thailand Sanofi-Aventis Investigational Site Number 764002 Bangkok-Noi
Tunisia Sanofi-Aventis Investigational Site Number 788003 Manouba
Tunisia Sanofi-Aventis Investigational Site Number 788004 Sfax
Tunisia Sanofi-Aventis Investigational Site Number 788001 Tunis
Tunisia Sanofi-Aventis Investigational Site Number 788002 Tunis
Turkey Sanofi-Aventis Investigational Site Number 792011 Edirne
Turkey Sanofi-Aventis Investigational Site Number 792001 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792007 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792009 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792010 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792012 Izmir
Turkey Sanofi-Aventis Investigational Site Number 792002 Kocaeli
Turkey Sanofi-Aventis Investigational Site Number 792003 Manisa
Turkey Sanofi-Aventis Investigational Site Number 792005 Samsun
Turkey Sanofi-Aventis Investigational Site Number 792004 Trabzon
Ukraine Sanofi-Aventis Investigational Site Number 804101 Chernihiv
Ukraine Sanofi-Aventis Investigational Site Number 804103 Dnipropetrovsk
Ukraine Sanofi-Aventis Investigational Site Number 804107 Donetsk
Ukraine Sanofi-Aventis Investigational Site Number 804117 Donetsk
Ukraine Sanofi-Aventis Investigational Site Number 804119 Ivano-Frankovsk
Ukraine Sanofi-Aventis Investigational Site Number 804102 Kharkiv
Ukraine Sanofi-Aventis Investigational Site Number 804109 Kharkov
Ukraine Sanofi-Aventis Investigational Site Number 804108 Kiev
Ukraine Sanofi-Aventis Investigational Site Number 804115 Kiev
Ukraine Sanofi-Aventis Investigational Site Number 804116 Kiev
Ukraine Sanofi-Aventis Investigational Site Number 804111 Lutsk
Ukraine Sanofi-Aventis Investigational Site Number 804124 Lutsk
Ukraine Sanofi-Aventis Investigational Site Number 804114 Lviv
Ukraine Sanofi-Aventis Investigational Site Number 804121 Lviv
Ukraine Sanofi-Aventis Investigational Site Number 804120 Poltava
Ukraine Sanofi-Aventis Investigational Site Number 804105 Vinnytsya
Ukraine Sanofi-Aventis Investigational Site Number 804118 Zaporizhya
Ukraine Sanofi-Aventis Investigational Site Number 804104 Zaporizhzhia
Ukraine Sanofi-Aventis Investigational Site Number 804122 Zaporozhye
United Kingdom Sanofi-Aventis Investigational Site Number 826002 Edinburgh
United Kingdom Sanofi-Aventis Investigational Site Number 826004 Haywards Heath
United Kingdom Sanofi-Aventis Investigational Site Number 826001 Irvine
United Kingdom Sanofi-Aventis Investigational Site Number 826003 Leeds
United Kingdom Sanofi-Aventis Investigational Site Number 826005 Salford
United States Sanofi-Aventis Investigational Site Number 840006 Bennington Vermont
United States Sanofi-Aventis Investigational Site Number 840074 Bismarck North Dakota
United States Sanofi-Aventis Investigational Site Number 840020 Charleston West Virginia
United States Sanofi-Aventis Investigational Site Number 840029 Charlotte North Carolina
United States Sanofi-Aventis Investigational Site Number 840026 Cincinnati Ohio
United States Sanofi-Aventis Investigational Site Number 840069 Clinton Township Michigan
United States Sanofi-Aventis Investigational Site Number 840071 Cordova Tennessee
United States Sanofi-Aventis Investigational Site Number 840078 Dayton Ohio
United States Sanofi-Aventis Investigational Site Number 840016 Des Moines Iowa
United States Sanofi-Aventis Investigational Site Number 840063 Elk Grove Village Illinois
United States Sanofi-Aventis Investigational Site Number 840011 Fairfield Connecticut
United States Sanofi-Aventis Investigational Site Number 840064 Flossmoor Illinois
United States Sanofi-Aventis Investigational Site Number 840090 Fort Collins Colorado
United States Sanofi-Aventis Investigational Site Number 840039 Ft Wayne Indiana
United States Sanofi-Aventis Investigational Site Number 840075 Grand Rapids Michigan
United States Sanofi-Aventis Investigational Site Number 840068 Greenville South Carolina
United States Sanofi-Aventis Investigational Site Number 840012 Indianapolis Indiana
United States Sanofi-Aventis Investigational Site Number 840008 Loma Linda California
United States Sanofi-Aventis Investigational Site Number 840013 Maitland Florida
United States Sanofi-Aventis Investigational Site Number 840076 Minneapolis Minnesota
United States Sanofi-Aventis Investigational Site Number 840034 Modesto California
United States Sanofi-Aventis Investigational Site Number 840036 Nashville Tennessee
United States Sanofi-Aventis Investigational Site Number 840083 Ocala Florida
United States Sanofi-Aventis Investigational Site Number 840086 Ormond Beach Florida
United States Sanofi-Aventis Investigational Site Number 840022 Philadelphia Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840073 Philadelphia Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840041 Phoenix Arizona
United States Sanofi-Aventis Investigational Site Number 840024 Portland Oregon
United States Sanofi-Aventis Investigational Site Number 840007 San Antonio Texas
United States Sanofi-Aventis Investigational Site Number 840025 Sarasota Florida
United States Sanofi-Aventis Investigational Site Number 840089 Seattle Washington
United States Sanofi-Aventis Investigational Site Number 840088 St. Louis Missouri
United States Sanofi-Aventis Investigational Site Number 840015 St. Petersburg Florida
United States Sanofi-Aventis Investigational Site Number 840033 Sunrise Florida
United States Sanofi-Aventis Investigational Site Number 840060 Syracuse New York
United States Sanofi-Aventis Investigational Site Number 840061 Traverse City Michigan
United States Sanofi-Aventis Investigational Site Number 840084 Tucson Arizona
United States Sanofi-Aventis Investigational Site Number 840066 Tulsa Oklahoma
United States Sanofi-Aventis Investigational Site Number 840079 Tupelo Mississippi

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Canada,  Chile,  China,  Czech Republic,  Estonia,  France,  Germany,  Greece,  Mexico,  Netherlands,  Philippines,  Poland,  Romania,  Slovakia,  Spain,  Sweden,  Thailand,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.
Hepatic parameters thresholds were defined as follows:
Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
Alkaline Phosphatase >1.5 ULN;
Total Bilirubin (TB) >1.5 or 2 ULN;
ALT >3 ULN and TB >2 ULN.
From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first Yes
Primary Annualized Relapse Rate (ARR): Poisson Regression Estimate ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).
Core treatment period between 48 - 152 weeks depending on time of enrollment No
Secondary Time to Disability Progression Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].
Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time =t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
Core treatment period between 48 - 152 weeks depending on time of enrollment No
Secondary Time Without Relapse Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.
Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake.
Core treatment period between 48 - 152 weeks depending on time of enrollment No
Secondary Change From Baseline to Week 48 in EDSS Total Score EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.
EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).
Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model.
Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48 No
Secondary Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model.
Baseline (before randomization), Week 12, Week 24 and Week 48 No
Secondary Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors). Baseline (before randomization) and up to Week 152 No
Secondary Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Two summary scores are obtained:
the physical health component summary score,
the mental health component summary score.
Both scores range from 0 to 100 and a high score indicates a more favorable health state.
Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model.
Baseline (before randomization), Week 12, Week 24 and Week 48 No
Secondary Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors). Baseline (before randomization) and up to Week 152 No
Secondary Overview of Adverse Events Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first Yes
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