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An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis (TOWER)

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Teriflunomide

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring relapsing multiple sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Teriflunomide 7 mg / 14 mg

Teriflunomide 14 mg / 14 mg

Placebo / Teriflunomide 14 mg

Arm Description

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Outcomes

Primary Outcome Measures

Core Treatment Period: 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).

Secondary Outcome Measures

Core Treatment Period: 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: 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: Change From Baseline to Week 48 in EDSS Total Score

EDSS is an ordinal scale in half-point increments that qualifies disability in participants 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.

Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score

FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants 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.

Core Treatment Period: 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).

Core Treatment Period: 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.

Core Treatment Period: 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).

Core Treatment Period: 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.

Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)

AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Extension Treatment Period: Time to Disability Progression

Probability of disability progression since the randomization of the core period 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 was 1 minus the probability of being event-free for the amount of time t.

Extension Treatment Period: ARR: Poisson Regression Estimate

ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in 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 enrolment and baseline EDSS stratum as covariates).

Full Information

NCT ID

NCT00751881

First Posted

May 7, 2008

Last Updated

May 27, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00751881

Brief Title

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Acronym

TOWER

Official Title

A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

relapsing multiple sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriflunomide 7 mg / 14 mg

Arm Type

Experimental

Arm Description

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Arm Title

Teriflunomide 14 mg / 14 mg

Arm Type

Experimental

Arm Description

Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Arm Title

Placebo / Teriflunomide 14 mg

Arm Type

Placebo Comparator

Arm Description

Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Film-coated tablet Oral administration

Intervention Type

Drug

Intervention Name(s)

Teriflunomide

Other Intervention Name(s)

HMR1726

Intervention Description

Film-coated tablet Oral administration

Primary Outcome Measure Information:

Title

Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate

Description

Time Frame

Core treatment period between 48 - 152 weeks depending on time of enrollment

Secondary Outcome Measure Information:

Title

Core Treatment Period: Time to Disability Progression

Description

Time Frame

Core treatment period between 48 - 152 weeks depending on time of enrollment

Title

Core Treatment Period: Time Without Relapse

Description

Time Frame

Core treatment period between 48 - 152 weeks depending on time of enrollment

Title

Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score

Description

Time Frame

Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48

Title

Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score

Description

Time Frame

Baseline (before randomization), Week 12, Week 24 and Week 48

Title

Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score

Description

Time Frame

Baseline (before randomization) and up to Week 152

Title

Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores

Description

Time Frame

Baseline (before randomization), Week 12, Week 24 and Week 48

Title

Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores

Description

Time Frame

Baseline (before randomization) and up to Week 152

Title

Core Treatment Period: Overview of Adverse Events

Description

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.

Time Frame

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

Title

Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)

Description

AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Time Frame

From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period

Title

Extension Treatment Period: Time to Disability Progression

Description

Time Frame

Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)

Title

Extension Treatment Period: ARR: Poisson Regression Estimate

Description

Time Frame

Extension treatment period (Maximum: 174 weeks)

Other Pre-specified Outcome Measures:

Title

Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Investigational Site Number 840041

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85060

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840084

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741-3537

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840008

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840034

City

Modesto

State/Province

California

ZIP/Postal Code

95355

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840090

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840011

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06430

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840013

City

Maitland

State/Province

Florida

ZIP/Postal Code

32761

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840083

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840086

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840025

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840015

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840033

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840063

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840064

City

Flossmoor

State/Province

Illinois

ZIP/Postal Code

60402

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840039

City

Ft Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840012

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840016

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840069

City

Clinton Township

State/Province

Michigan

ZIP/Postal Code

48035

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840075

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840061

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840076

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840079

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840088

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840060

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840029

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840074

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840026

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840078

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840066

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74137

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840024

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840073

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840022

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840068

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840071

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840036

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840007

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840006

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840089

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840020

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25301

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 036005

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036006

City

Chatswood

ZIP/Postal Code

2067

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036003

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036004

City

Geelong

ZIP/Postal Code

3220

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036008

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036002

City

New Lambton

ZIP/Postal Code

2305

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 036001

City

Sydney

ZIP/Postal Code

2050

Country

Australia

Facility Name

Sanofi-Aventis Investigational Site Number 040001

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 112105

City

Grodno

Country

Belarus

Facility Name

Sanofi-Aventis Investigational Site Number 112102

City

Minsk

ZIP/Postal Code

220226

Country

Belarus

Facility Name

Sanofi-Aventis Investigational Site Number 112101

City

Minsk

Country

Belarus

Facility Name

Sanofi-Aventis Investigational Site Number 112104

City

Minsk

Country

Belarus

Facility Name

Sanofi-Aventis Investigational Site Number 112103

City

Vitebsk

Country

Belarus

Facility Name

Sanofi-Aventis Investigational Site Number 056004

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056002

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056001

City

Melsbroek

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 056003

City

Sijsele-Damme

Country

Belgium

Facility Name

Sanofi-Aventis Investigational Site Number 124004

City

Gatineau

ZIP/Postal Code

J9J 0A5

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124002

City

Kingston

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124007

City

Montreal

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124008

City

Ottawa

ZIP/Postal Code

K2G 6E2

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124001

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124003

City

Regina

ZIP/Postal Code

S4T 1A5

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 124006

City

Saint John

ZIP/Postal Code

E2L 3L6

Country

Canada

Facility Name

Sanofi-Aventis Investigational Site Number 152006

City

Santiago

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152007

City

Santiago

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152002

City

Viña Del Mar

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 156023

City

Baotou

ZIP/Postal Code

014010

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156031

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156006

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156010

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156005

City

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156032

City

Beijing

ZIP/Postal Code

100068

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156024

City

Beijing

ZIP/Postal Code

100088

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156030

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156001

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156008

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156007

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156002

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156025

City

Guangzhou

ZIP/Postal Code

510260

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156012

City

Guangzhou

ZIP/Postal Code

510630

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156027

City

Haikou

ZIP/Postal Code

570102

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156021

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156033

City

Jinan

ZIP/Postal Code

250033

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156034

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156011

City

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156019

City

Qingdao

ZIP/Postal Code

266003

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156029

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156016

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156009

City

Shenyang

ZIP/Postal Code

110001

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156022

City

Shijiazhuang

ZIP/Postal Code

050051

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156018

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156028

City

Taiyuan

ZIP/Postal Code

030001

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156003

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156035

City

Tianjin

ZIP/Postal Code

300211

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156017

City

Wenzhou

ZIP/Postal Code

325000

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156004

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156014

City

Xi'An

ZIP/Postal Code

710032

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 156015

City

Xi'An

ZIP/Postal Code

710061

Country

China

Facility Name

Sanofi-Aventis Investigational Site Number 203001

City

Brno

ZIP/Postal Code

65691

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203002

City

Ostrava - Poruba

ZIP/Postal Code

70852

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203004

City

Teplice

ZIP/Postal Code

415 29

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 233002

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Sanofi-Aventis Investigational Site Number 233001

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Sanofi-Aventis Investigational Site Number 250005

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250008

City

Dijon Cedex

ZIP/Postal Code

21033

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250001

City

Lyon Cedex 03

ZIP/Postal Code

69394

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250007

City

Nantes Cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250006

City

Nice Cedex

ZIP/Postal Code

06002

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250002

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 250003

City

Poissy

ZIP/Postal Code

78300

Country

France

Facility Name

Sanofi-Aventis Investigational Site Number 276010

City

Bamberg

ZIP/Postal Code

96047

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276003

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276005

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276001

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276006

City

Gießen

ZIP/Postal Code

35385

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276004

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276007

City

Leipzig

ZIP/Postal Code

04157

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276009

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276002

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 300001

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 300006

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Sanofi-Aventis Investigational Site Number 484005

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 484003

City

México

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 528003

City

'S Hertogenbosch

ZIP/Postal Code

5211 NL

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528001

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528002

City

Groesbeek

ZIP/Postal Code

6561 KE

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528004

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 528006

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Sanofi-Aventis Investigational Site Number 608004

City

Cebu City

Country

Philippines

Facility Name

Sanofi-Aventis Investigational Site Number 608002

City

Makati City

ZIP/Postal Code

1229

Country

Philippines

Facility Name

Sanofi-Aventis Investigational Site Number 608001

City

Manila

Country

Philippines

Facility Name

Sanofi-Aventis Investigational Site Number 608003

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Sanofi-Aventis Investigational Site Number 616002

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616005

City

Lodz

ZIP/Postal Code

90-549

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616001

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616004

City

Szczecin

ZIP/Postal Code

70-215

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616003

City

Warszawa 44

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 642006

City

Bacau

ZIP/Postal Code

600114

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642005

City

Brasov

ZIP/Postal Code

500123

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642001

City

Bucuresti

ZIP/Postal Code

010584

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642007

City

Oradea

ZIP/Postal Code

410154

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 703003

City

Bratislava 2

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Sanofi-Aventis Investigational Site Number 703005

City

Bratislava 2

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Sanofi-Aventis Investigational Site Number 703001

City

Martin

ZIP/Postal Code

03659

Country

Slovakia

Facility Name

Sanofi-Aventis Investigational Site Number 703006

City

Presov

ZIP/Postal Code

08181

Country

Slovakia

Facility Name

Sanofi-Aventis Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724007

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724002

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724004

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724003

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 752002

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 752001

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 752003

City

Stockholm

ZIP/Postal Code

182 88

Country

Sweden

Facility Name

Sanofi-Aventis Investigational Site Number 764002

City

Bangkok-Noi

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Sanofi-Aventis Investigational Site Number 764001

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Sanofi-Aventis Investigational Site Number 788003

City

Manouba

ZIP/Postal Code

2010

Country

Tunisia

Facility Name

Sanofi-Aventis Investigational Site Number 788004

City

Sfax

ZIP/Postal Code

3029

Country

Tunisia

Facility Name

Sanofi-Aventis Investigational Site Number 788002

City

Tunis

ZIP/Postal Code

1006

Country

Tunisia

Facility Name

Sanofi-Aventis Investigational Site Number 788001

City

Tunis

ZIP/Postal Code

1007

Country

Tunisia

Facility Name

Sanofi-Aventis Investigational Site Number 792011

City

Edirne

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792009

City

Istanbul

ZIP/Postal Code

34147

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792001

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792007

City

Istanbul

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792010

City

Istanbul

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792012

City

Izmir

ZIP/Postal Code

35380

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792002

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792003

City

Manisa

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792005

City

Samsun

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792004

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 804101

City

Chernihiv

ZIP/Postal Code

14025

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804103

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804107

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804117

City

Donetsk

ZIP/Postal Code

83099

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804119

City

Ivano-Frankovsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804102

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804109

City

Kharkov

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804115

City

Kiev

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804116

City

Kiev

ZIP/Postal Code

04112

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804108

City

Kiev

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804111

City

Lutsk

ZIP/Postal Code

43005

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804124

City

Lutsk

ZIP/Postal Code

43024

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804114

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804121

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804120

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804105

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804118

City

Zaporizhya

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804104

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 804122

City

Zaporozhye

ZIP/Postal Code

69000

Country

Ukraine

Facility Name

Sanofi-Aventis Investigational Site Number 826002

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826004

City

Haywards Heath

ZIP/Postal Code

RH16 4EX

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826001

City

Irvine

ZIP/Postal Code

KA12 8SS

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826003

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

Sanofi-Aventis Investigational Site Number 826005

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24461574

Citation

Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.

Results Reference

result

PubMed Identifier

33023488

Citation

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.

Results Reference

derived

PubMed Identifier

32911306

Citation

Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.

Results Reference

derived

PubMed Identifier

30511679

Citation

Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.

Results Reference

derived

PubMed Identifier

29796289

Citation

Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

Results Reference

derived

PubMed Identifier

28304217

Citation

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.

Results Reference

derived

Learn more about this trial

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

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An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis (TOWER)

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial