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

NCT ID: NCT01895335

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1001 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriflunomide

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

Group Type: EXPERIMENTAL

Teriflunomide

Intervention Type: DRUG

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

Interventions

Teriflunomide

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

Intervention Type: DRUG

Other Intervention Names

HMR1726; Aubagio®

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,

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840077

Birmingham, Alabama, United States

Investigational Site Number 840007

Cullman, Alabama, United States

Investigational Site Number 840087

Phoenix, Arizona, United States

Investigational Site Number 840114

Phoenix, Arizona, United States

Investigational Site Number 840080

Scottsdale, Arizona, United States

Investigational Site Number 840032

Tucson, Arizona, United States

Investigational Site Number 840021

Phoenix, Arkansas, United States

Investigational Site Number 840018

Fullerton, California, United States

Investigational Site Number 840037

Fullerton, California, United States

Investigational Site Number 840108

Long Beach, California, United States

Investigational Site Number 840014

Newport Beach, California, United States

Investigational Site Number 840019

Oceanside, California, United States

Investigational Site Number 840097

Boulder, Colorado, United States

Investigational Site Number 840040

Colorado Springs, Colorado, United States

Investigational Site Number 840046

Denver, Colorado, United States

Investigational Site Number 840016

Englewood, Colorado, United States

Investigational Site Number 840094

Fort Collins, Colorado, United States

Investigational Site Number 840024

Bradenton, Florida, United States

Investigational Site Number 840089

Clearwater, Florida, United States

Investigational Site Number 840055

Coconut Creek, Florida, United States

Investigational Site Number 840104

Hialeah, Florida, United States

Investigational Site Number 840101

Miami Lakes, Florida, United States

Investigational Site Number 840011

Ormond Beach, Florida, United States

Investigational Site Number 840059

Sarasota, Florida, United States

Investigational Site Number 840008

St. Petersburg, Florida, United States

Investigational Site Number 840081

Sunrise, Florida, United States

Investigational Site Number 840002

Atlanta, Georgia, United States

Investigational Site Number 840075

Macon, Georgia, United States

Investigational Site Number 840012

Fort Wayne, Indiana, United States

Investigational Site Number 840010

Indianapolis, Indiana, United States

Investigational Site Number 840034

Louisville, Kentucky, United States

Investigational Site Number 840047

Rockport, Maine, United States

Investigational Site Number 840107

Foxborough, Massachusetts, United States

Investigational Site Number 840030

Springfield, Massachusetts, United States

Investigational Site Number 840073

Clinton Township, Michigan, United States

Investigational Site Number 840068

Golden Valley, Minnesota, United States

Investigational Site Number 840098

Golden Valley, Minnesota, United States

Investigational Site Number 840086

Chesterfield, Missouri, United States

Investigational Site Number 840058

St Louis, Missouri, United States

Investigational Site Number 840026

Lincoln, Nebraska, United States

Investigational Site Number 840020

Henderson, Nevada, United States

Investigational Site Number 840049

Freehold, New Jersey, United States

Investigational Site Number 840044

Toms River, New Jersey, United States

Investigational Site Number 840100

East Setauket, New York, United States

Investigational Site Number 840064

New York, New York, United States

Investigational Site Number 840005

New York, New York, United States

Investigational Site Number 840071

Schenectady, New York, United States

Investigational Site Number 840091

Staten Island, New York, United States

Investigational Site Number 840045

Syracuse, New York, United States

Investigational Site Number 840084

Asheville, North Carolina, United States

Investigational Site Number 840078

Charlotte, North Carolina, United States

Investigational Site Number 840042

Raliegh, North Carolina, United States

Investigational Site Number 840105

Sanford, North Carolina, United States

Investigational Site Number 840074

Wilmington, North Carolina, United States

Investigational Site Number 840090

Winston-Salem, North Carolina, United States

Investigational Site Number 840041

Bismarck, North Dakota, United States

Investigational Site Number 840003

Canton, Ohio, United States

Investigational Site Number 840009

Dayton, Ohio, United States

Investigational Site Number 840053

Monaca, Pennsylvania, United States

Investigational Site Number 840056

Philadelphia, Pennsylvania, United States

Investigational Site Number 840072

Cranston, Rhode Island, United States

Investigational Site Number 840048

Nashville, Tennessee, United States

Investigational Site Number 840035

Tullahoma, Tennessee, United States

Investigational Site Number 840060

Dallas, Texas, United States

Investigational Site Number 840052

Mansfield, Texas, United States

Investigational Site Number 840028

San Antonio, Texas, United States

Investigational Site Number 840070

Henrico, Virginia, United States

Investigational Site Number 840109

Richmond, Virginia, United States

Investigational Site Number 840017

Roanoke, Virginia, United States

Investigational Site Number 840054

Vienna, Virginia, United States

Investigational Site Number 840069

Spokane, Washington, United States

Investigational Site Number 840079

Morgantown, West Virginia, United States

Investigational Site Number 840038

Milwaukee, Wisconsin, United States

Investigational Site Number 840112

Milwaukee, Wisconsin, United States

Investigational Site Number 840076

Neenah, Wisconsin, United States

Investigational Site Number 040-001

Linz, , Austria

Investigational Site Number 040-002

Vienna, , Austria

Investigational Site Number 056006

Brasschaat, , Belgium

Investigational Site Number 056001

Brussels, , Belgium

Investigational Site Number 056003

Edegem, , Belgium

Investigational Site Number 056002

Kortrijk, , Belgium

Investigational Site Number 056007

Leuven, , Belgium

Investigational Site Number 056008

Liège, , Belgium

Investigational Site Number 056009

Liège, , Belgium

Investigational Site Number 056005

Melsbroek, , Belgium

Investigational Site Number 124006

Cambridge, , Canada

Investigational Site Number 124007

St. John's, , Canada

Investigational Site Number 152003

Concepción, , Chile

Investigational Site Number 152001

Santiago, , Chile

Investigational Site Number 152005

Santiago, , Chile

Investigational Site Number 246004

Hämeenlinna, , Finland

Investigational Site Number 246005

Kuopio, , Finland

Investigational Site Number 246006

Oulu, , Finland

Investigational Site Number 246001

Turku, , Finland

Investigational Site Number 246003

Turku, , Finland

Investigational Site Number 250002

Agen, , France

Investigational Site Number 250003

Aix-en-Provence, , France

Investigational Site Number 250004

Albi, , France

Investigational Site Number 250005

Amiens, , France

Investigational Site Number 250006

Bayonne, , France

Investigational Site Number 250007

Bordeaux, , France

Investigational Site Number 250008

Caen, , France

Investigational Site Number 250009

Cahors, , France

Investigational Site Number 250011

Chambéry, , France

Investigational Site Number 250012

Colmar, , France

Investigational Site Number 250001

Dijon, , France

Investigational Site Number 250015

Grenoble, , France

Investigational Site Number 250017

Le Mans, , France

Investigational Site Number 250018

Lille, , France

Investigational Site Number 250019

Limoges, , France

Investigational Site Number 250020

Lyon, , France

Investigational Site Number 250021

Marseille, , France

Investigational Site Number 250022

Metz-Tessy, , France

Investigational Site Number 250023

Montbéliard, , France

Investigational Site Number 250024

Montpellier, , France

Investigational Site Number 250025

Mulhouse, , France

Investigational Site Number 250026

Nancy, , France

Investigational Site Number 250027

Nantes, , France

Investigational Site Number 250028

Nîmes, , France

Investigational Site Number 250016

Paris, , France

Investigational Site Number 250029

Paris, , France

Investigational Site Number 250043

Pau, , France

Investigational Site Number 250031

Quimper, , France

Investigational Site Number 250032

Reims, , France

Investigational Site Number 250033

Rouen, , France

Investigational Site Number 250030

Saint-Germain-en-Laye, , France

Investigational Site Number 250035

Strasbourg, , France

Investigational Site Number 250037

Toulouse, , France

Investigational Site Number 250038

Tours, , France

Investigational Site Number 250039

Valence, , France

Investigational Site Number 250040

Valenciennes, , France

Investigational Site Number 250013

Vichy, , France

Investigational Site Number 276001

Bergisch Gladbach, , Germany

Investigational Site Number 276003

Berlin, , Germany

Investigational Site Number 276004

Freiburg im Breisgau, , Germany

Investigational Site Number 300002

Athens, , Greece

Investigational Site Number 300001

Athens, , Greece

Investigational Site Number 300005

Larissa, , Greece

Investigational Site Number 300004

Thessaloniki, , Greece

Investigational Site Number 380008

Ancona, , Italy

Investigational Site Number 380009

Bari, , Italy

Investigational Site Number 380002

Gallarate (VA), , Italy

Investigational Site Number 380001

Milan, , Italy

Investigational Site Number 380004

Milan, , Italy

Investigational Site Number 380006

Napoli, , Italy

Investigational Site Number 380005

Orbassano (TO), , Italy

Investigational Site Number 578002

Bergen, , Norway

Investigational Site Number 578003

Namsos, , Norway

Investigational Site Number 578001

Oslo, , Norway

Investigational Site Number 724004

A Coruña, , Spain

Investigational Site Number 724002

Barcelona, , Spain

Investigational Site Number 724010

Córdoba, , Spain

Investigational Site Number 724008

Donostia / San Sebastian, , Spain

Investigational Site Number 724001

El Palmar (murcia), , Spain

Investigational Site Number 724006

Santiago de Compostela, , Spain

Investigational Site Number 724007

Valencia, , Spain

Investigational Site Number 724005

Valladolid, , Spain

Investigational Site Number 752001

Karlstad, , Sweden

Investigational Site Number 752003

Kungsbacka, , Sweden

Investigational Site Number 752002

Motala, , Sweden

Investigational Site Number 826-005

Birmingham, , United Kingdom

Investigational Site Number 826-003

Brighton, , United Kingdom

Investigational Site Number 826-007

Glasgow, , United Kingdom

Investigational Site Number 826-008

Leeds, , United Kingdom

Investigational Site Number 826-010

Leicester, , United Kingdom

Investigational Site Number 826-009

London, , United Kingdom

Investigational Site Number 826-001

Norwich, , United Kingdom

Investigational Site Number 826-006

Romford, , United Kingdom

Investigational Site Number 826-004

Salford, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Chile; Finland; France; Germany; Greece; Italy; Norway; Spain; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31005729 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29055438 (View on PubMed)

Other Identifiers

U1111-1139-8730

Identifier Type: OTHER

Identifier Source: secondary_id

LPS13567

Identifier Type: -

Identifier Source: org_study_id