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

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).

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Teriflunomide

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.

• Study Type: Interventional
• Enrollment (Actual): 1001
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Investigational Site Number 040-001
  • Wien, Austria
    • Investigational Site Number 040-002
• Belgium
  • Brasschaat, Belgium, 2930
    • Investigational Site Number 056006
  • Bruxelles, Belgium, 1200
    • Investigational Site Number 056001
  • Edegem, Belgium, 2650
    • Investigational Site Number 056003
  • Kortrijk, Belgium, 8500
    • Investigational Site Number 056002
  • Leuven, Belgium, 3000
    • Investigational Site Number 056007
  • Liège, Belgium, 4000
    • Investigational Site Number 056009
  • Liège, Belgium, 4000
    • Investigational Site Number 056008
  • Melsbroek, Belgium, 1820
    • Investigational Site Number 056005
• Canada
  • Cambridge, Canada, N1R7L6
    • Investigational Site Number 124006
  • St. John, Canada, E2L 4L2
    • Investigational Site Number 124007
• Chile
  • Concepcion, Chile
    • Investigational Site Number 152003
  • Santiago, Chile
    • Investigational Site Number 152005
  • Santiago, Chile
    • Investigational Site Number 152001
• Finland
  • Hämeenlinna, Finland, 13530
    • Investigational Site Number 246004
  • Kuopio, Finland
    • Investigational Site Number 246005
  • Oulu, Finland, 90220
    • Investigational Site Number 246006
  • Turku, Finland, 20520
    • Investigational Site Number 246003
  • Turku, Finland, 20520
    • Investigational Site Number 246001
• France
  • Agen Cedex, France, 47923
    • Investigational Site Number 250002
  • Aix En Provence, France, 13616
    • Investigational Site Number 250003
  • Albi, France, 81000
    • Investigational Site Number 250004
  • Amiens Cedex 1, France, 80054
    • Investigational Site Number 250005
  • Bayonne, France, 64109
    • Investigational Site Number 250006
  • Bordeaux, France, 33000
    • Investigational Site Number 250007
  • CAHORS Cedex 9, France, 46005
    • Investigational Site Number 250009
  • Caen, France, 14000
    • Investigational Site Number 250008
  • Chambery, France, 73000
    • Investigational Site Number 250011
  • Colmar, France, 68024
    • Investigational Site Number 250012
  • Dijon, France, 21000
    • Investigational Site Number 250001
  • GRENOBLE cedex, France, 38043
    • Investigational Site Number 250015
  • Le Mans Cedex 9, France, 72037
    • Investigational Site Number 250017
  • Lille Cedex, France, 59037
    • Investigational Site Number 250018
  • Limoges Cedex, France, 87000
    • Investigational Site Number 250019
  • Lyon Cedex 03, France, 69275
    • Investigational Site Number 250020
  • MONTPELLIER Cedex 5, France, 34295
    • Investigational Site Number 250024
  • Marseille, France, 13008
    • Investigational Site Number 250021
  • Metz-Tessy, France, 74370
    • Investigational Site Number 250022
  • Montbeliard, France, 25200
    • Investigational Site Number 250023
  • Mulhouse, France, 68100
    • Investigational Site Number 250025
  • Nancy, France
    • Investigational Site Number 250026
  • Nantes, France, 44093
    • Investigational Site Number 250027
  • Nimes, France, 30029
    • Investigational Site Number 250028
  • PARIS Cedex 13, France, 75013
    • Investigational Site Number 250016
  • PARIS Cedex 20, France, 75970
    • Investigational Site Number 250029
  • Pau, France, 64000
    • Investigational Site Number 250043
  • Quimper, France, 29000
    • Investigational Site Number 250031
  • Reims, France, 51100
    • Investigational Site Number 250032
  • Rouen, France, 76000
    • Investigational Site Number 250033
  • St Germain En Laye, France, 78100
    • Investigational Site Number 250030
  • Strasbourg, France, 67091
    • Investigational Site Number 250035
  • Toulouse, France, 31200
    • Investigational Site Number 250037
  • Tours, France, 37044
    • Investigational Site Number 250038
  • VICHY Cedex, France, 03201
    • Investigational Site Number 250013
  • Valence Cedex 9, France, 26953
    • Investigational Site Number 250039
  • Valenciennes, France, 59322
    • Investigational Site Number 250040
• Germany
  • Bergisch-Gladbach, Germany, 51429
    • Investigational Site Number 276001
  • Berlin, Germany, 12099
    • Investigational Site Number 276003
  • Freiburg, Germany, 79098
    • Investigational Site Number 276004
• Greece
  • Athens, Greece, 11521
    • Investigational Site Number 300002
  • Athens, Greece, 11525
    • Investigational Site Number 300001
  • Larissa, Greece, 41110
    • Investigational Site Number 300005
  • Thessaloniki, Greece, 546 36
    • Investigational Site Number 300004
• Italy
  • Ancona, Italy, 60126
    • Investigational Site Number 380008
  • Bari, Italy, 70124
    • Investigational Site Number 380009
  • Gallarate (VA), Italy, 21013
    • Investigational Site Number 380002
  • Milano, Italy, 20132
    • Investigational Site Number 380001
  • Milano, Italy, 20133
    • Investigational Site Number 380004
  • Napoli, Italy, 80138
    • Investigational Site Number 380006
  • Orbassano (TO), Italy, 10043
    • Investigational Site Number 380005
• Norway
  • Bergen, Norway, 5021
    • Investigational Site Number 578002
  • Namsos, Norway, 7800
    • Investigational Site Number 578003
  • Oslo, Norway, 0407
    • Investigational Site Number 578001
• Spain
  • Barcelona, Spain, 08035
    • Investigational Site Number 724002
  • Córdoba, Spain, 14004
    • Investigational Site Number 724010
  • Donostia, Spain, 20014
    • Investigational Site Number 724008
  • El Palmar (MURCIA), Spain, 30120
    • Investigational Site Number 724001
  • La Coruña, Spain, 15006
    • Investigational Site Number 724004
  • Santiago de Compostela, Spain, 15706
    • Investigational Site Number 724006
  • Valencia, Spain, 46009
    • Investigational Site Number 724007
  • Valladolid, Spain, 47011
    • Investigational Site Number 724005
• Sweden
  • Karlstad, Sweden, 65185
    • Investigational Site Number 752001
  • Kungsbacka, Sweden, 43480
    • Investigational Site Number 752003
  • Motala, Sweden, 59185
    • Investigational Site Number 752002
• United Kingdom
  • Birmingham, United Kingdom, B152TH
    • Investigational Site Number 826-005
  • Brighton, United Kingdom, BN25BE
    • Investigational Site Number 826-003
  • Glasgow, United Kingdom, G116NT
    • Investigational Site Number 826-007
  • Leeds, United Kingdom, LS13EX
    • Investigational Site Number 826-008
  • Leicester, United Kingdom, LE54PW
    • Investigational Site Number 826-010
  • London, United Kingdom, SW170QT
    • Investigational Site Number 826-009
  • Norwich, United Kingdom, nr34dg
    • Investigational Site Number 826-001
  • Romford, United Kingdom, RM70AG
    • Investigational Site Number 826-006
  • Salford, United Kingdom, M68HD
    • Investigational Site Number 826-004
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Investigational Site Number 840077
    • Cullman, Alabama, United States
      • Investigational Site Number 840007
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Investigational Site Number 840087
    • Phoenix, Arizona, United States, 85008
      • Investigational Site Number 840114
    • Scottsdale, Arizona, United States, 85258
      • Investigational Site Number 840080
    • Tucson, Arizona, United States, 85704
      • Investigational Site Number 840032
  • Arkansas
    • Phoenix, Arkansas, United States
      • Investigational Site Number 840021
  • California
    • Fullerton, California, United States, 92835
      • Investigational Site Number 840018
    • Fullerton, California, United States, 92835
      • Investigational Site Number 840037
    • Long Beach, California, United States, 90806
      • Investigational Site Number 840108
    • Newport Beach, California, United States, 92663
      • Investigational Site Number 840014
    • Oceanside, California, United States, 92056
      • Investigational Site Number 840019
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Investigational Site Number 840097
    • Colorado Springs, Colorado, United States, 80907
      • Investigational Site Number 840040
    • Denver, Colorado, United States, CO
      • Investigational Site Number 840046
    • Englewood, Colorado, United States, 80113
      • Investigational Site Number 840016
    • Fort Collins, Colorado, United States, 80528
      • Investigational Site Number 840094
  • Florida
    • Bradenton, Florida, United States, FL
      • Investigational Site Number 840024
    • Clearwater, Florida, United States, 33756
      • Investigational Site Number 840089
    • Coconut Creek, Florida, United States, 33073
      • Investigational Site Number 840055
    • Hialeah, Florida, United States, 33013
      • Investigational Site Number 840104
    • Miami Lakes, Florida, United States, 33014
      • Investigational Site Number 840101
    • Ormond Beach, Florida, United States
      • Investigational Site Number 840011
    • Sarasota, Florida, United States, 34239
      • Investigational Site Number 840059
    • St. Petersburg, Florida, United States
      • Investigational Site Number 840008
    • Sunrise, Florida, United States, 33351
      • Investigational Site Number 840081
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Investigational Site Number 840002
    • Macon, Georgia, United States, 31210
      • Investigational Site Number 840075
  • Indiana
    • Fort Wayne, Indiana, United States
      • Investigational Site Number 840012
    • Indianapolis, Indiana, United States
      • Investigational Site Number 840010
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Investigational Site Number 840034
  • Maine
    • Rockport, Maine, United States, 04843
      • Investigational Site Number 840047
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Investigational Site Number 840107
    • Springfield, Massachusetts, United States, 01104
      • Investigational Site Number 840030
  • Michigan
    • Clinton Township, Michigan, United States, 48035
      • Investigational Site Number 840073
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Investigational Site Number 840068
    • Golden Valley, Minnesota, United States, 55422
      • Investigational Site Number 840098
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Investigational Site Number 840086
    • St. Louis, Missouri, United States, 63110
      • Investigational Site Number 840058
  • Nebraska
    • Lincoln, Nebraska, United States, 68521
      • Investigational Site Number 840026
  • Nevada
    • Henderson, Nevada, United States, 89012
      • Investigational Site Number 840020
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Investigational Site Number 840049
    • Toms River, New Jersey, United States, 08755
      • Investigational Site Number 840044
  • New York
    • East Setauket, New York, United States, 11733-345
      • Investigational Site Number 840100
    • NY, New York, United States, 14203
      • Investigational Site Number 840064
    • New York, New York, United States
      • Investigational Site Number 840005
    • Schenectady, New York, United States, 12308
      • Investigational Site Number 840071
    • Staten Island, New York, United States, 10306
      • Investigational Site Number 840091
    • Syracuse, New York, United States, 13202
      • Investigational Site Number 840045
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Investigational Site Number 840084
    • Charlotte, North Carolina, United States, 28204
      • Investigational Site Number 840078
    • Raliegh, North Carolina, United States
      • Investigational Site Number 840042
    • Sanford, North Carolina, United States
      • Investigational Site Number 840105
    • Wilmington, North Carolina, United States, 28401
      • Investigational Site Number 840074
    • Winston Salem, North Carolina, United States, 27103
      • Investigational Site Number 840090
  • North Dakota
    • Bismarck, North Dakota, United States
      • Investigational Site Number 840041
  • Ohio
    • Canton, Ohio, United States, 44718
      • Investigational Site Number 840003
    • Dayton, Ohio, United States
      • Investigational Site Number 840009
  • Pennsylvania
    • Monaca, Pennsylvania, United States, 15061
      • Investigational Site Number 840053
    • Philadelphia, Pennsylvania, United States, 19107
      • Investigational Site Number 840056
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Investigational Site Number 840072
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Investigational Site Number 840048
    • Tullahoma, Tennessee, United States, 37388
      • Investigational Site Number 840035
  • Texas
    • Dallas, Texas, United States, 75246
      • Investigational Site Number 840060
    • Mansfield, Texas, United States, 76063
      • Investigational Site Number 840052
    • San Antonio, Texas, United States, 78229
      • Investigational Site Number 840028
  • Virginia
    • Henrico, Virginia, United States, 23226
      • Investigational Site Number 840070
    • Richmond, Virginia, United States, 23298
      • Investigational Site Number 840109
    • Roanoke, Virginia, United States, 24018
      • Investigational Site Number 840017
    • Vienna, Virginia, United States, 22182
      • Investigational Site Number 840054
  • Washington
    • Spokane, Washington, United States, 99220-3649
      • Investigational Site Number 840069
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9180
      • Investigational Site Number 840079
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Investigational Site Number 840038
    • Milwaukee, Wisconsin, United States
      • Investigational Site Number 840112
    • Neenah, Wisconsin, United States, 54956
      • Investigational Site Number 840076

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teriflunomide; Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.	Drug: Teriflunomide; Pharmaceutical form: film-coated tablet; Route of administration: oral; Other Names: HMR1726; Aubagio®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Baseline, Week 4, Week 48
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.	Week 4, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 24, Week 48
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.	Baseline up to end of treatment (up to Week 48)
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.	Baseline up to end of treatment (up to Week 48)
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.	Baseline, Week 48
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.	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
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.	Baseline up to end of treatment (up to Week 48)
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).	Baseline up to end of treatment (up to Week 48)
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.	Baseline, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Teriflunomide
• Other Study ID Numbers: LPS13567; U1111-1139-8730 (Other Identifier: UTN)