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

NCT01895335 | Completed Phase 4 Results

• 2 other identifiers: LPS13567U1111-1139-8730
• Study Type: interventional
• Target: 1,001
• Locations: 14 countries
• Sites: 169

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (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.

  Week 48

Secondary Outcomes (13)

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

  Baseline, Week 4, Week 48

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

  Week 4, Week 48

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

  Baseline, Week 48

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

  Baseline, Week 24, Week 48

• Annualized Treated Relapse Rate

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

Study Arms (1)

Teriflunomide

EXPERIMENTAL

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

Drug: Teriflunomide

Interventions

Teriflunomide DRUG

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

Also known as: HMR1726, Aubagio®

Teriflunomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Sanofi: lead

Study Sites (169)

Investigational Site Number 840077

Birmingham, Alabama, 35209, United States

Location

Investigational Site Number 840007

Cullman, Alabama, United States

Location

Investigational Site Number 840087

Phoenix, Arizona, 85004, United States

Location

Investigational Site Number 840114

Phoenix, Arizona, 85008, United States

Location

Investigational Site Number 840080

Scottsdale, Arizona, 85258, United States

Location

Investigational Site Number 840032

Tucson, Arizona, 85704, United States

Location

Investigational Site Number 840021

Phoenix, Arkansas, United States

Location

Investigational Site Number 840018

Fullerton, California, 92835, United States

Location

Investigational Site Number 840037

Fullerton, California, 92835, United States

Location

Investigational Site Number 840108

Long Beach, California, 90806, United States

Location

Investigational Site Number 840014

Newport Beach, California, 92663, United States

Location

Investigational Site Number 840019

Oceanside, California, 92056, United States

Location

Investigational Site Number 840097

Boulder, Colorado, 80304, United States

Location

Investigational Site Number 840040

Colorado Springs, Colorado, 80907, United States

Location

Investigational Site Number 840046

Denver, Colorado, CO, United States

Location

Investigational Site Number 840016

Englewood, Colorado, 80113, United States

Location

Investigational Site Number 840094

Fort Collins, Colorado, 80528, United States

Location

Investigational Site Number 840024

Bradenton, Florida, FL, United States

Location

Investigational Site Number 840089

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 840055

Coconut Creek, Florida, 33073, United States

Location

Investigational Site Number 840104

Hialeah, Florida, 33013, United States

Location

Investigational Site Number 840101

Miami Lakes, Florida, 33014, United States

Location

Investigational Site Number 840011

Ormond Beach, Florida, United States

Location

Investigational Site Number 840059

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840008

St. Petersburg, Florida, United States

Location

Investigational Site Number 840081

Sunrise, Florida, 33351, United States

Location

Investigational Site Number 840002

Atlanta, Georgia, 30318, United States

Location

Investigational Site Number 840075

Macon, Georgia, 31210, United States

Location

Investigational Site Number 840012

Fort Wayne, Indiana, United States

Location

Investigational Site Number 840010

Indianapolis, Indiana, United States

Location

Investigational Site Number 840034

Louisville, Kentucky, 40207, United States

Location

Investigational Site Number 840047

Rockport, Maine, 04843, United States

Location

Investigational Site Number 840107

Foxborough, Massachusetts, 02035, United States

Location

Investigational Site Number 840030

Springfield, Massachusetts, 01104, United States

Location

Investigational Site Number 840073

Clinton Township, Michigan, 48035, United States

Location

Investigational Site Number 840068

Golden Valley, Minnesota, 55422, United States

Location

Investigational Site Number 840098

Golden Valley, Minnesota, 55422, United States

Location

Investigational Site Number 840086

Chesterfield, Missouri, 63017, United States

Location

Investigational Site Number 840058

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 840026

Lincoln, Nebraska, 68521, United States

Location

Investigational Site Number 840020

Henderson, Nevada, 89012, United States

Location

Investigational Site Number 840049

Freehold, New Jersey, 07728, United States

Location

Investigational Site Number 840044

Toms River, New Jersey, 08755, United States

Location

Investigational Site Number 840100

East Setauket, New York, 11733-345, United States

Location

Investigational Site Number 840064

New York, New York, 14203, United States

Location

Investigational Site Number 840005

New York, New York, United States

Location

Investigational Site Number 840071

Schenectady, New York, 12308, United States

Location

Investigational Site Number 840091

Staten Island, New York, 10306, United States

Location

Investigational Site Number 840045

Syracuse, New York, 13202, United States

Location

Investigational Site Number 840084

Asheville, North Carolina, 28806, United States

Location

Investigational Site Number 840078

Charlotte, North Carolina, 28204, United States

Location

Investigational Site Number 840042

Raliegh, North Carolina, United States

Location

Investigational Site Number 840105

Sanford, North Carolina, United States

Location

Investigational Site Number 840074

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840090

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 840041

Bismarck, North Dakota, United States

Location

Investigational Site Number 840003

Canton, Ohio, 44718, United States

Location

Investigational Site Number 840009

Dayton, Ohio, United States

Location

Investigational Site Number 840053

Monaca, Pennsylvania, 15061, United States

Location

Investigational Site Number 840056

Philadelphia, Pennsylvania, 19107, United States

Location

Investigational Site Number 840072

Cranston, Rhode Island, 02920, United States

Location

Investigational Site Number 840048

Nashville, Tennessee, 37215, United States

Location

Investigational Site Number 840035

Tullahoma, Tennessee, 37388, United States

Location

Investigational Site Number 840060

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840052

Mansfield, Texas, 76063, United States

Location

Investigational Site Number 840028

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 840070

Henrico, Virginia, 23226, United States

Location

Investigational Site Number 840109

Richmond, Virginia, 23298, United States

Location

Investigational Site Number 840017

Roanoke, Virginia, 24018, United States

Location

Investigational Site Number 840054

Vienna, Virginia, 22182, United States

Location

Investigational Site Number 840069

Spokane, Washington, 99220-3649, United States

Location

Investigational Site Number 840079

Morgantown, West Virginia, 26506-9180, United States

Location

Investigational Site Number 840038

Milwaukee, Wisconsin, 53215, United States

Location

Investigational Site Number 840112

Milwaukee, Wisconsin, United States

Location

Investigational Site Number 840076

Neenah, Wisconsin, 54956, United States

Location

Investigational Site Number 040-001

Linz, Austria

Location

Investigational Site Number 040-002

Vienna, Austria

Location

Investigational Site Number 056006

Brasschaat, 2930, Belgium

Location

Investigational Site Number 056001

Brussels, 1200, Belgium

Location

Investigational Site Number 056003

Edegem, 2650, Belgium

Location

Investigational Site Number 056002

Kortrijk, 8500, Belgium

Location

Investigational Site Number 056007

Leuven, 3000, Belgium

Location

Investigational Site Number 056008

Liège, 4000, Belgium

Location

Investigational Site Number 056009

Liège, 4000, Belgium

Location

Investigational Site Number 056005

Melsbroek, 1820, Belgium

Location

Investigational Site Number 124006

Cambridge, N1R7L6, Canada

Location

Investigational Site Number 124007

St. John's, E2L 4L2, Canada

Location

Investigational Site Number 152003

Concepción, Chile

Location

Investigational Site Number 152001

Santiago, Chile

Location

Investigational Site Number 152005

Santiago, Chile

Location

Investigational Site Number 246004

Hämeenlinna, 13530, Finland

Location

Investigational Site Number 246005

Kuopio, Finland

Location

Investigational Site Number 246006

Oulu, 90220, Finland

Location

Investigational Site Number 246001

Turku, 20520, Finland

Location

Investigational Site Number 246003

Turku, 20520, Finland

Location

Investigational Site Number 250002

Agen, 47923, France

Location

Investigational Site Number 250003

Aix-en-Provence, 13616, France

Location

Investigational Site Number 250004

Albi, 81000, France

Location

Investigational Site Number 250005

Amiens, 80054, France

Location

Investigational Site Number 250006

Bayonne, 64109, France

Location

Investigational Site Number 250007

Bordeaux, 33000, France

Location

Investigational Site Number 250008

Caen, 14000, France

Location

Investigational Site Number 250009

Cahors, 46005, France

Location

Investigational Site Number 250011

Chambéry, 73000, France

Location

Investigational Site Number 250012

Colmar, 68024, France

Location

Investigational Site Number 250001

Dijon, 21000, France

Location

Investigational Site Number 250015

Grenoble, 38043, France

Location

Investigational Site Number 250017

Le Mans, 72037, France

Location

Investigational Site Number 250018

Lille, 59037, France

Location

Investigational Site Number 250019

Limoges, 87000, France

Location

Investigational Site Number 250020

Lyon, 69275, France

Location

Investigational Site Number 250021

Marseille, 13008, France

Location

Investigational Site Number 250022

Metz-Tessy, 74370, France

Location

Investigational Site Number 250023

Montbéliard, 25200, France

Location

Investigational Site Number 250024

Montpellier, 34295, France

Location

Investigational Site Number 250025

Mulhouse, 68100, France

Location

Investigational Site Number 250026

Nancy, France

Location

Investigational Site Number 250027

Nantes, 44093, France

Location

Investigational Site Number 250028

Nîmes, 30029, France

Location

Investigational Site Number 250016

Paris, 75013, France

Location

Investigational Site Number 250029

Paris, 75970, France

Location

Investigational Site Number 250043

Pau, 64000, France

Location

Investigational Site Number 250031

Quimper, 29000, France

Location

Investigational Site Number 250032

Reims, 51100, France

Location

Investigational Site Number 250033

Rouen, 76000, France

Location

Investigational Site Number 250030

Saint-Germain-en-Laye, 78100, France

Location

Investigational Site Number 250035

Strasbourg, 67091, France

Location

Investigational Site Number 250037

Toulouse, 31200, France

Location

Investigational Site Number 250038

Tours, 37044, France

Location

Investigational Site Number 250039

Valence, 26953, France

Location

Investigational Site Number 250040

Valenciennes, 59322, France

Location

Investigational Site Number 250013

Vichy, 03201, France

Location

Investigational Site Number 276001

Bergisch Gladbach, 51429, Germany

Location

Investigational Site Number 276003

Berlin, 12099, Germany

Location

Investigational Site Number 276004

Freiburg im Breisgau, 79098, Germany

Location

Investigational Site Number 300002

Athens, 11521, Greece

Location

Investigational Site Number 300001

Athens, 11525, Greece

Location

Investigational Site Number 300005

Larissa, 41110, Greece

Location

Investigational Site Number 300004

Thessaloniki, 546 36, Greece

Location

Investigational Site Number 380008

Ancona, 60126, Italy

Location

Investigational Site Number 380009

Bari, 70124, Italy

Location

Investigational Site Number 380002

Gallarate (VA), 21013, Italy

Location

Investigational Site Number 380001

Milan, 20132, Italy

Location

Investigational Site Number 380004

Milan, 20133, Italy

Location

Investigational Site Number 380006

Napoli, 80138, Italy

Location

Investigational Site Number 380005

Orbassano (TO), 10043, Italy

Location

Investigational Site Number 578002

Bergen, 5021, Norway

Location

Investigational Site Number 578003

Namsos, 7800, Norway

Location

Investigational Site Number 578001

Oslo, 0407, Norway

Location

Investigational Site Number 724004

A Coruña, 15006, Spain

Location

Investigational Site Number 724002

Barcelona, 08035, Spain

Location

Investigational Site Number 724010

Córdoba, 14004, Spain

Location

Investigational Site Number 724008

Donostia / San Sebastian, 20014, Spain

Location

Investigational Site Number 724001

El Palmar (murcia), 30120, Spain

Location

Investigational Site Number 724006

Santiago de Compostela, 15706, Spain

Location

Investigational Site Number 724007

Valencia, 46009, Spain

Location

Investigational Site Number 724005

Valladolid, 47011, Spain

Location

Investigational Site Number 752001

Karlstad, 65185, Sweden

Location

Investigational Site Number 752003

Kungsbacka, 43480, Sweden

Location

Investigational Site Number 752002

Motala, 59185, Sweden

Location

Investigational Site Number 826-005

Birmingham, B152TH, United Kingdom

Location

Investigational Site Number 826-003

Brighton, BN25BE, United Kingdom

Location

Investigational Site Number 826-007

Glasgow, G116NT, United Kingdom

Location

Investigational Site Number 826-008

Leeds, LS13EX, United Kingdom

Location

Investigational Site Number 826-010

Leicester, LE54PW, United Kingdom

Location

Investigational Site Number 826-009

London, SW170QT, United Kingdom

Location

Investigational Site Number 826-001

Norwich, nr34dg, United Kingdom

Location

Investigational Site Number 826-006

Romford, RM70AG, United Kingdom

Location

Investigational Site Number 826-004

Salford, M68HD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31005729 DERIVED

• 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.

  PMID: 29055438 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 6, 2016
• Results First Posted: December 6, 2016

Record last verified: 2016-10

Locations

GR (4); IT (7); CL (3); ES (8); SE (3); GB (9); NO (3); FI (5); BE (8); CA (2); AU (2); FR (37); DE (3); US (75)