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Multiple SclerosisPhase 4TERI-PRONCT01895335

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

A Phase 4 study testing Teriflunomide in people with Multiple Sclerosis, run by Sanofi at 169 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Teriflunomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,001 participants
Where
169 sitesin 14 countries
Study dates
Jun 2013to Nov 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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),
Show all 18Show fewer
  • 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.

Trial locations and contacts

169 sites in 14 countries.

169 sites in 14 countries

United States75 sites

  • Investigational Site Number 840084

    Asheville, North Carolina, 28806

  • Investigational Site Number 840002

    Atlanta, Georgia, 30318

  • Investigational Site Number 840077

    Birmingham, Alabama, 35209

  • Investigational Site Number 840041

    Bismarck, North Dakota

  • Investigational Site Number 840097

    Boulder, Colorado, 80304

  • Investigational Site Number 840024

    Bradenton, Florida, FL

  • Investigational Site Number 840003

    Canton, Ohio, 44718

  • Investigational Site Number 840078

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840086

    Chesterfield, Missouri, 63017

  • Investigational Site Number 840089

    Clearwater, Florida, 33756

  • Investigational Site Number 840073

    Clinton Township, Michigan, 48035

  • Investigational Site Number 840055

    Coconut Creek, Florida, 33073

  • Investigational Site Number 840040

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840072

    Cranston, Rhode Island, 02920

  • Investigational Site Number 840007

    Cullman, Alabama

  • Investigational Site Number 840060

    Dallas, Texas, 75246

  • Investigational Site Number 840009

    Dayton, Ohio

  • Investigational Site Number 840046

    Denver, Colorado, CO

  • Investigational Site Number 840100

    East Setauket, New York, 11733-345

  • Investigational Site Number 840016

    Englewood, Colorado, 80113

  • Investigational Site Number 840094

    Fort Collins, Colorado, 80528

  • Investigational Site Number 840012

    Fort Wayne, Indiana

  • Investigational Site Number 840107

    Foxborough, Massachusetts, 02035

  • Investigational Site Number 840049

    Freehold, New Jersey, 07728

  • Investigational Site Number 840018

    Fullerton, California, 92835

  • Investigational Site Number 840037

    Fullerton, California, 92835

  • Investigational Site Number 840068

    Golden Valley, Minnesota, 55422

  • Investigational Site Number 840098

    Golden Valley, Minnesota, 55422

  • Investigational Site Number 840020

    Henderson, Nevada, 89012

  • Investigational Site Number 840070

    Henrico, Virginia, 23226

  • Investigational Site Number 840104

    Hialeah, Florida, 33013

  • Investigational Site Number 840010

    Indianapolis, Indiana

  • Investigational Site Number 840026

    Lincoln, Nebraska, 68521

  • Investigational Site Number 840108

    Long Beach, California, 90806

  • Investigational Site Number 840034

    Louisville, Kentucky, 40207

  • Investigational Site Number 840075

    Macon, Georgia, 31210

  • Investigational Site Number 840052

    Mansfield, Texas, 76063

  • Investigational Site Number 840101

    Miami Lakes, Florida, 33014

  • Investigational Site Number 840038

    Milwaukee, Wisconsin, 53215

  • Investigational Site Number 840112

    Milwaukee, Wisconsin

  • Investigational Site Number 840053

    Monaca, Pennsylvania, 15061

  • Investigational Site Number 840079

    Morgantown, West Virginia, 26506-9180

  • Investigational Site Number 840048

    Nashville, Tennessee, 37215

  • Investigational Site Number 840076

    Neenah, Wisconsin, 54956

  • Investigational Site Number 840064

    New York, New York, 14203

  • Investigational Site Number 840005

    New York, New York

  • Investigational Site Number 840014

    Newport Beach, California, 92663

  • Investigational Site Number 840019

    Oceanside, California, 92056

  • Investigational Site Number 840011

    Ormond Beach, Florida

  • Investigational Site Number 840056

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 840087

    Phoenix, Arizona, 85004

  • Investigational Site Number 840114

    Phoenix, Arizona, 85008

  • Investigational Site Number 840021

    Phoenix, Arkansas

  • Investigational Site Number 840042

    Raliegh, North Carolina

  • Investigational Site Number 840109

    Richmond, Virginia, 23298

  • Investigational Site Number 840017

    Roanoke, Virginia, 24018

  • Investigational Site Number 840047

    Rockport, Maine, 04843

  • Investigational Site Number 840028

    San Antonio, Texas, 78229

  • Investigational Site Number 840105

    Sanford, North Carolina

  • Investigational Site Number 840059

    Sarasota, Florida, 34239

  • Investigational Site Number 840071

    Schenectady, New York, 12308

  • Investigational Site Number 840080

    Scottsdale, Arizona, 85258

  • Investigational Site Number 840069

    Spokane, Washington, 99220-3649

  • Investigational Site Number 840030

    Springfield, Massachusetts, 01104

  • Investigational Site Number 840058

    St Louis, Missouri, 63110

  • Investigational Site Number 840008

    St. Petersburg, Florida

  • Investigational Site Number 840091

    Staten Island, New York, 10306

  • Investigational Site Number 840081

    Sunrise, Florida, 33351

  • Investigational Site Number 840045

    Syracuse, New York, 13202

  • Investigational Site Number 840044

    Toms River, New Jersey, 08755

  • Investigational Site Number 840032

    Tucson, Arizona, 85704

  • Investigational Site Number 840035

    Tullahoma, Tennessee, 37388

  • Investigational Site Number 840054

    Vienna, Virginia, 22182

  • Investigational Site Number 840074

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840090

    Winston-Salem, North Carolina, 27103

Other trials in United States

France37 sites

  • Investigational Site Number 250002

    Agen, 47923

  • Investigational Site Number 250003

    Aix-en-Provence, 13616

  • Investigational Site Number 250004

    Albi, 81000

  • Investigational Site Number 250005

    Amiens, 80054

  • Investigational Site Number 250006

    Bayonne, 64109

  • Investigational Site Number 250007

    Bordeaux, 33000

  • Investigational Site Number 250008

    Caen, 14000

  • Investigational Site Number 250009

    Cahors, 46005

  • Investigational Site Number 250011

    Chambéry, 73000

  • Investigational Site Number 250012

    Colmar, 68024

  • Investigational Site Number 250001

    Dijon, 21000

  • Investigational Site Number 250015

    Grenoble, 38043

  • Investigational Site Number 250017

    Le Mans, 72037

  • Investigational Site Number 250018

    Lille, 59037

  • Investigational Site Number 250019

    Limoges, 87000

  • Investigational Site Number 250020

    Lyon, 69275

  • Investigational Site Number 250021

    Marseille, 13008

  • Investigational Site Number 250022

    Metz-Tessy, 74370

  • Investigational Site Number 250023

    Montbéliard, 25200

  • Investigational Site Number 250024

    Montpellier, 34295

  • Investigational Site Number 250025

    Mulhouse, 68100

  • Investigational Site Number 250026

    Nancy

  • Investigational Site Number 250027

    Nantes, 44093

  • Investigational Site Number 250028

    Nîmes, 30029

  • Investigational Site Number 250016

    Paris, 75013

  • Investigational Site Number 250029

    Paris, 75970

  • Investigational Site Number 250043

    Pau, 64000

  • Investigational Site Number 250031

    Quimper, 29000

  • Investigational Site Number 250032

    Reims, 51100

  • Investigational Site Number 250033

    Rouen, 76000

  • Investigational Site Number 250030

    Saint-Germain-en-Laye, 78100

  • Investigational Site Number 250035

    Strasbourg, 67091

  • Investigational Site Number 250037

    Toulouse, 31200

  • Investigational Site Number 250038

    Tours, 37044

  • Investigational Site Number 250039

    Valence, 26953

  • Investigational Site Number 250040

    Valenciennes, 59322

  • Investigational Site Number 250013

    Vichy, 03201

Other trials in France

United Kingdom9 sites

  • Investigational Site Number 826-005

    Birmingham, B152TH

  • Investigational Site Number 826-003

    Brighton, BN25BE

  • Investigational Site Number 826-007

    Glasgow, G116NT

  • Investigational Site Number 826-008

    Leeds, LS13EX

  • Investigational Site Number 826-010

    Leicester, LE54PW

  • Investigational Site Number 826-009

    London, SW170QT

  • Investigational Site Number 826-001

    Norwich, nr34dg

  • Investigational Site Number 826-006

    Romford, RM70AG

  • Investigational Site Number 826-004

    Salford, M68HD

Other trials in United Kingdom

Belgium8 sites

  • Investigational Site Number 056006

    Brasschaat, 2930

  • Investigational Site Number 056001

    Brussels, 1200

  • Investigational Site Number 056003

    Edegem, 2650

  • Investigational Site Number 056002

    Kortrijk, 8500

  • Investigational Site Number 056007

    Leuven, 3000

  • Investigational Site Number 056008

    Liège, 4000

  • Investigational Site Number 056009

    Liège, 4000

  • Investigational Site Number 056005

    Melsbroek, 1820

Other trials in Belgium

Spain8 sites

  • Investigational Site Number 724004

    A Coruña, 15006

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724010

    Córdoba, 14004

  • Investigational Site Number 724008

    Donostia / San Sebastian, 20014

  • Investigational Site Number 724001

    El Palmar (murcia), 30120

  • Investigational Site Number 724006

    Santiago de Compostela, 15706

  • Investigational Site Number 724007

    Valencia, 46009

  • Investigational Site Number 724005

    Valladolid, 47011

Other trials in Spain

Italy7 sites

  • Investigational Site Number 380008

    Ancona, 60126

  • Investigational Site Number 380009

    Bari, 70124

  • Investigational Site Number 380002

    Gallarate (VA), 21013

  • Investigational Site Number 380001

    Milan, 20132

  • Investigational Site Number 380004

    Milan, 20133

  • Investigational Site Number 380006

    Naples, 80138

  • Investigational Site Number 380005

    Orbassano (TO), 10043

Other trials in Italy

Finland5 sites

  • Investigational Site Number 246004

    Hämeenlinna, 13530

  • Investigational Site Number 246005

    Kuopio

  • Investigational Site Number 246006

    Oulu, 90220

  • Investigational Site Number 246001

    Turku, 20520

  • Investigational Site Number 246003

    Turku, 20520

Other trials in Finland

Greece4 sites

  • Investigational Site Number 300002

    Athens, 11521

  • Investigational Site Number 300001

    Athens, 11525

  • Investigational Site Number 300005

    Larissa, 41110

  • Investigational Site Number 300004

    Thessaloniki, 546 36

Other trials in Greece

Chile3 sites

  • Investigational Site Number 152003

    Concepción

  • Investigational Site Number 152001

    Santiago

  • Investigational Site Number 152005

    Santiago

Other trials in Chile

Germany3 sites

  • Investigational Site Number 276001

    Bergisch Gladbach, 51429

  • Investigational Site Number 276003

    Berlin, 12099

  • Investigational Site Number 276004

    Freiburg im Breisgau, 79098

Other trials in Germany

Norway3 sites

  • Investigational Site Number 578002

    Bergen, 5021

  • Investigational Site Number 578003

    Namsos, 7800

  • Investigational Site Number 578001

    Oslo, 0407

Other trials in Norway

Sweden3 sites

  • Investigational Site Number 752001

    Karlstad, 65185

  • Investigational Site Number 752003

    Kungsbacka, 43480

  • Investigational Site Number 752002

    Motala, 59185

Other trials in Sweden

Austria2 sites

  • Investigational Site Number 040-001

    Linz

  • Investigational Site Number 040-002

    Vienna

Other trials in Austria

Canada2 sites

  • Investigational Site Number 124006

    Cambridge, N1R7L6

  • Investigational Site Number 124007

    St. John's, E2L 4L2

Other trials in Canada

About this study

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

Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).

Read more

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.

Read the 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.

Being tested
Teriflunomide
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeriflunomideDrug

    Also called HMR1726, Aubagio®

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

Study groups in NCT01895335
Study groupRoleWhat they receive
TeriflunomideExperimentalTeriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
Receives: Drug: Teriflunomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 48

Secondary outcomes (13)

  1. 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 .

    Measured: Baseline, Week 4, Week 48

  2. 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.

    Measured: Week 4, Week 48

  3. 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.

    Measured: Baseline, Week 48

  4. 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.

    Measured: Baseline, Week 24, Week 48

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: Baseline, Week 48

  8. 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.

    Measured: 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

  9. 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.

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

  10. 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).

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

  11. 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.

    Measured: Baseline, Week 48

  12. 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.

    Measured: Baseline, Week 48

  13. 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.

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,001 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01895335
Sponsor's protocol ID
LPS13567
Other IDs
U1111-1139-8730
Acronym
TERI-PRO
Status last verified
Oct 2016
First submitted
3 Jul 2013
Last updated
6 Dec 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 31005729

  • 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.

    PubMed 29055438

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teriflunomide in people with Multiple Sclerosis, run by Sanofi at 169 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, France, United Kingdom, Belgium, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01895335, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.

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