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Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients (TERI-PRO)

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Teriflunomide

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent.

Exclusion criteria:

According to local labelling,
Less than 18 years of age,
Current or history of receiving teriflunomide,
Previous treatment with leflunomide within 6 months prior to baseline,
Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),
Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
Women who were pregnant or breast-feeding,
Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics [SmPC]):
- Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
- Participants with severe active infection until resolution,
- Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
- Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Hypersensitivity to the active substance or to any of the excipients,
Other additional contraindications per local labeling.

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 Type

Experimental

Arm Label

Teriflunomide

Arm Description

Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.

Outcomes

Primary Outcome Measures

Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Secondary Outcome Measures

Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .

Change From Week 4 in TSQM Scores in Naïve Participants to Week 48

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.

Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48

PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.

Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48

MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.

Annualized Treated Relapse Rate

Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.

Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48

A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.

Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48

SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.

Overview of Adverse Events (AEs)

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period

Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.

Duration of Teriflunomide Treatment Exposure

Duration of exposure was defined as last dose date - first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).

Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48

The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.

Change From Baseline in Stern Leisure Activity Scale at Week 48

The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant's participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.

Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48

EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.

Full Information

NCT ID

NCT01895335

First Posted

July 3, 2013

Last Updated

October 10, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01895335

Brief Title

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

Acronym

TERI-PRO

Official Title

A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant. To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

Detailed Description

The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed): Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.

6. Conditions and Keywords

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

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriflunomide

Arm Type

Experimental

Arm Description

Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.

Intervention Type

Drug

Intervention Name(s)

Teriflunomide

Other Intervention Name(s)

HMR1726, Aubagio®

Intervention Description

Pharmaceutical form: film-coated tablet; Route of administration: oral

Primary Outcome Measure Information:

Title

Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48

Description

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48

Description

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .

Time Frame

Baseline, Week 4, Week 48

Title

Change From Week 4 in TSQM Scores in Naïve Participants to Week 48

Description

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.

Time Frame

Week 4, Week 48

Title

Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48

Description

Time Frame

Baseline, Week 24, Week 48

Title

Annualized Treated Relapse Rate

Description

Time Frame

Baseline up to end of treatment (up to Week 48)

Title

Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48

Description

Time Frame

Baseline up to end of treatment (up to Week 48)

Title

Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Overview of Adverse Events (AEs)

Description

Time Frame

From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP

Title

Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period

Description

Time Frame

Baseline up to end of treatment (up to Week 48)

Title

Duration of Teriflunomide Treatment Exposure

Description

Duration of exposure was defined as last dose date - first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).

Time Frame

Baseline up to end of treatment (up to Week 48)

Title

Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in Stern Leisure Activity Scale at Week 48

Description

Time Frame

Baseline, Week 48

Title

Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48

Description

Time Frame

Baseline, Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent. Exclusion criteria: According to local labelling, Less than 18 years of age, Current or history of receiving teriflunomide, Previous treatment with leflunomide within 6 months prior to baseline, Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN), Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice), Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections, Women who were pregnant or breast-feeding, Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study, Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study, Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics [SmPC]): Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia, Participants with severe active infection until resolution, Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group, Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome. Hypersensitivity to the active substance or to any of the excipients, Other additional contraindications per local labeling. 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

Investigational Site Number 840077

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Investigational Site Number 840007

City

Cullman

State/Province

Alabama

Country

United States

Facility Name

Investigational Site Number 840087

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Investigational Site Number 840114

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

Country

United States

Facility Name

Investigational Site Number 840080

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Investigational Site Number 840032

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Investigational Site Number 840021

City

Phoenix

State/Province

Arkansas

Country

United States

Facility Name

Investigational Site Number 840018

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Investigational Site Number 840037

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Investigational Site Number 840108

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Investigational Site Number 840014

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Investigational Site Number 840019

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Investigational Site Number 840097

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Investigational Site Number 840040

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Investigational Site Number 840046

City

Denver

State/Province

Colorado

ZIP/Postal Code

Country

United States

Facility Name

Investigational Site Number 840016

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Investigational Site Number 840094

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Investigational Site Number 840024

City

Bradenton

State/Province

Florida

ZIP/Postal Code

Country

United States

Facility Name

Investigational Site Number 840089

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Investigational Site Number 840055

City

Coconut Creek

State/Province

Florida

ZIP/Postal Code

33073

Country

United States

Facility Name

Investigational Site Number 840104

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

Investigational Site Number 840101

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Investigational Site Number 840011

City

Ormond Beach

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840059

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840008

City

St. Petersburg

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840081

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Investigational Site Number 840002

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Investigational Site Number 840075

City

Macon

State/Province

Georgia

ZIP/Postal Code

31210

Country

United States

Facility Name

Investigational Site Number 840012

City

Fort Wayne

State/Province

Indiana

Country

United States

Facility Name

Investigational Site Number 840010

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Investigational Site Number 840034

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Investigational Site Number 840047

City

Rockport

State/Province

Maine

ZIP/Postal Code

04843

Country

United States

Facility Name

Investigational Site Number 840107

City

Foxboro

State/Province

Massachusetts

ZIP/Postal Code

02035

Country

United States

Facility Name

Investigational Site Number 840030

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01104

Country

United States

Facility Name

Investigational Site Number 840073

City

Clinton Township

State/Province

Michigan

ZIP/Postal Code

48035

Country

United States

Facility Name

Investigational Site Number 840068

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Investigational Site Number 840098

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Investigational Site Number 840086

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Investigational Site Number 840058

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Investigational Site Number 840026

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68521

Country

United States

Facility Name

Investigational Site Number 840020

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89012

Country

United States

Facility Name

Investigational Site Number 840049

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Investigational Site Number 840044

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Investigational Site Number 840100

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733-345

Country

United States

Facility Name

Investigational Site Number 840005

City

New York

State/Province

New York

Country

United States

Facility Name

Investigational Site Number 840064

City

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

Investigational Site Number 840071

City

Schenectady

State/Province

New York

ZIP/Postal Code

12308

Country

United States

Facility Name

Investigational Site Number 840091

City

Staten Island

State/Province

New York

ZIP/Postal Code

10306

Country

United States

Facility Name

Investigational Site Number 840045

City

Syracuse

State/Province

New York

ZIP/Postal Code

13202

Country

United States

Facility Name

Investigational Site Number 840084

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Investigational Site Number 840078

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Investigational Site Number 840042

City

Raliegh

State/Province

North Carolina

Country

United States

Facility Name

Investigational Site Number 840105

City

Sanford

State/Province

North Carolina

Country

United States

Facility Name

Investigational Site Number 840074

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 840090

City

Winston Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840041

City

Bismarck

State/Province

North Dakota

Country

United States

Facility Name

Investigational Site Number 840003

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Investigational Site Number 840009

City

Dayton

State/Province

Ohio

Country

United States

Facility Name

Investigational Site Number 840053

City

Monaca

State/Province

Pennsylvania

ZIP/Postal Code

15061

Country

United States

Facility Name

Investigational Site Number 840056

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Investigational Site Number 840072

City

Cranston

State/Province

Rhode Island

ZIP/Postal Code

02920

Country

United States

Facility Name

Investigational Site Number 840048

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Investigational Site Number 840035

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37388

Country

United States

Facility Name

Investigational Site Number 840060

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site Number 840052

City

Mansfield

State/Province

Texas

ZIP/Postal Code

76063

Country

United States

Facility Name

Investigational Site Number 840028

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 840070

City

Henrico

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Investigational Site Number 840109

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Investigational Site Number 840017

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Investigational Site Number 840054

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22182

Country

United States

Facility Name

Investigational Site Number 840069

City

Spokane

State/Province

Washington

ZIP/Postal Code

99220-3649

Country

United States

Facility Name

Investigational Site Number 840079

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9180

Country

United States

Facility Name

Investigational Site Number 840038

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Investigational Site Number 840112

City

Milwaukee

State/Province

Wisconsin

Country

United States

Facility Name

Investigational Site Number 840076

City

Neenah

State/Province

Wisconsin

ZIP/Postal Code

54956

Country

United States

Facility Name

Investigational Site Number 040-001

City

Linz

Country

Austria

Facility Name

Investigational Site Number 040-002

City

Wien

Country

Austria

Facility Name

Investigational Site Number 056006

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Investigational Site Number 056003

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Investigational Site Number 056002

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Investigational Site Number 056007

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 056008

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigational Site Number 056009

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigational Site Number 056005

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

Investigational Site Number 124006

City

Cambridge

ZIP/Postal Code

N1R7L6

Country

Canada

Facility Name

Investigational Site Number 124007

City

St. John

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Investigational Site Number 152003

City

Concepcion

Country

Chile

Facility Name

Investigational Site Number 152001

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 152005

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 246004

City

Hämeenlinna

ZIP/Postal Code

13530

Country

Finland

Facility Name

Investigational Site Number 246005

City

Kuopio

Country

Finland

Facility Name

Investigational Site Number 246006

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Investigational Site Number 246001

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Investigational Site Number 246003

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Investigational Site Number 250002

City

Agen Cedex

ZIP/Postal Code

47923

Country

France

Facility Name

Investigational Site Number 250003

City

Aix En Provence

ZIP/Postal Code

13616

Country

France

Facility Name

Investigational Site Number 250004

City

Albi

ZIP/Postal Code

81000

Country

France

Facility Name

Investigational Site Number 250005

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Investigational Site Number 250006

City

Bayonne

ZIP/Postal Code

64109

Country

France

Facility Name

Investigational Site Number 250007

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Investigational Site Number 250008

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Investigational Site Number 250009

City

CAHORS Cedex 9

ZIP/Postal Code

46005

Country

France

Facility Name

Investigational Site Number 250011

City

Chambery

ZIP/Postal Code

73000

Country

France

Facility Name

Investigational Site Number 250012

City

Colmar

ZIP/Postal Code

68024

Country

France

Facility Name

Investigational Site Number 250001

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Investigational Site Number 250015

City

GRENOBLE cedex

ZIP/Postal Code

38043

Country

France

Facility Name

Investigational Site Number 250017

City

Le Mans Cedex 9

ZIP/Postal Code

72037

Country

France

Facility Name

Investigational Site Number 250018

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Investigational Site Number 250019

City

Limoges Cedex

ZIP/Postal Code

87000

Country

France

Facility Name

Investigational Site Number 250020

City

Lyon Cedex 03

ZIP/Postal Code

69275

Country

France

Facility Name

Investigational Site Number 250021

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

Investigational Site Number 250022

City

Metz-Tessy

ZIP/Postal Code

74370

Country

France

Facility Name

Investigational Site Number 250023

City

Montbeliard

ZIP/Postal Code

25200

Country

France

Facility Name

Investigational Site Number 250024

City

MONTPELLIER Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 250025

City

Mulhouse

ZIP/Postal Code

68100

Country

France

Facility Name

Investigational Site Number 250026

City

Nancy

Country

France

Facility Name

Investigational Site Number 250027

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250028

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Investigational Site Number 250016

City

PARIS Cedex 13

ZIP/Postal Code

75013

Country

France

Facility Name

Investigational Site Number 250029

City

PARIS Cedex 20

ZIP/Postal Code

75970

Country

France

Facility Name

Investigational Site Number 250043

City

Pau

ZIP/Postal Code

64000

Country

France

Facility Name

Investigational Site Number 250031

City

Quimper

ZIP/Postal Code

29000

Country

France

Facility Name

Investigational Site Number 250032

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Investigational Site Number 250033

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Investigational Site Number 250030

City

St Germain En Laye

ZIP/Postal Code

78100

Country

France

Facility Name

Investigational Site Number 250035

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Investigational Site Number 250037

City

Toulouse

ZIP/Postal Code

31200

Country

France

Facility Name

Investigational Site Number 250038

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Investigational Site Number 250039

City

Valence Cedex 9

ZIP/Postal Code

26953

Country

France

Facility Name

Investigational Site Number 250040

City

Valenciennes

ZIP/Postal Code

59322

Country

France

Facility Name

Investigational Site Number 250013

City

VICHY Cedex

ZIP/Postal Code

03201

Country

France

Facility Name

Investigational Site Number 276001

City

Bergisch-Gladbach

ZIP/Postal Code

51429

Country

Germany

Facility Name

Investigational Site Number 276003

City

Berlin

ZIP/Postal Code

12099

Country

Germany

Facility Name

Investigational Site Number 276004

City

Freiburg

ZIP/Postal Code

79098

Country

Germany

Facility Name

Investigational Site Number 300002

City

Athens

ZIP/Postal Code

11521

Country

Greece

Facility Name

Investigational Site Number 300001

City

Athens

ZIP/Postal Code

11525

Country

Greece

Facility Name

Investigational Site Number 300005

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Investigational Site Number 300004

City

Thessaloniki

ZIP/Postal Code

546 36

Country

Greece

Facility Name

Investigational Site Number 380008

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Investigational Site Number 380009

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Investigational Site Number 380002

City

Gallarate (VA)

ZIP/Postal Code

21013

Country

Italy

Facility Name

Investigational Site Number 380001

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 380004

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Investigational Site Number 380006

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Investigational Site Number 380005

City

Orbassano (TO)

ZIP/Postal Code

10043

Country

Italy

Facility Name

Investigational Site Number 578002

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Investigational Site Number 578003

City

Namsos

ZIP/Postal Code

7800

Country

Norway

Facility Name

Investigational Site Number 578001

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Investigational Site Number 724002

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 724010

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigational Site Number 724008

City

Donostia

ZIP/Postal Code

20014

Country

Spain

Facility Name

Investigational Site Number 724001

City

El Palmar (MURCIA)

ZIP/Postal Code

30120

Country

Spain

Facility Name

Investigational Site Number 724004

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724006

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 724007

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Investigational Site Number 724005

City

Valladolid

ZIP/Postal Code

47011

Country

Spain

Facility Name

Investigational Site Number 752001

City

Karlstad

ZIP/Postal Code

65185

Country

Sweden

Facility Name

Investigational Site Number 752003

City

Kungsbacka

ZIP/Postal Code

43480

Country

Sweden

Facility Name

Investigational Site Number 752002

City

Motala

ZIP/Postal Code

59185

Country

Sweden

Facility Name

Investigational Site Number 826-005

City

Birmingham

ZIP/Postal Code

B152TH

Country

United Kingdom

Facility Name

Investigational Site Number 826-003

City

Brighton

ZIP/Postal Code

BN25BE

Country

United Kingdom

Facility Name

Investigational Site Number 826-007

City

Glasgow

ZIP/Postal Code

G116NT

Country

United Kingdom

Facility Name

Investigational Site Number 826-008

City

Leeds

ZIP/Postal Code

LS13EX

Country

United Kingdom

Facility Name

Investigational Site Number 826-010

City

Leicester

ZIP/Postal Code

LE54PW

Country

United Kingdom

Facility Name

Investigational Site Number 826-009

City

London

ZIP/Postal Code

SW170QT

Country

United Kingdom

Facility Name

Investigational Site Number 826-001

City

Norwich

ZIP/Postal Code

nr34dg

Country

United Kingdom

Facility Name

Investigational Site Number 826-006

City

Romford

ZIP/Postal Code

RM70AG

Country

United Kingdom

Facility Name

Investigational Site Number 826-004

City

Salford

ZIP/Postal Code

M68HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31005729

Citation

Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Poole EM, Robinson M, Gold R. Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study. Mult Scler Relat Disord. 2019 Jun;31:157-164. doi: 10.1016/j.msard.2019.03.022. Epub 2019 Mar 30.

Results Reference

derived

PubMed Identifier

29055438

Citation

Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.

Results Reference

derived

Learn more about this trial

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

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Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients (TERI-PRO)

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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