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

Multiple Sclerosis Clinical Trial

— TERI-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895335
• Other study ID #: LPS13567
• Secondary ID: U1111-1139-8730
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2013
• Last updated: November 30, 2015
• Start date: June 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Secondary Objectives:

To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients.

To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients 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 Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

Description:

The total duration of the study per patient is 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 is possible and it is particularly recommended for women of child-bearing potential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patients with a relapsing form of multiple sclerosis (RMS) Having signed written informed consent

Exclusion criteria:

• ACCORDING TO LOCAL LABELING

• Less than 18 years of age

• Current or history of receiving teriflunomide

• Previous treatment with leflunomide within 6 months prior to baseline

• Patients 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

• Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections

• Women who are pregnant or breast-feeding

• Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use reliable contraception throughout the course of the study

• Male patients (only when required according to local labeling): unwilling to use reliable contraception during the course of the study

• Additional exclusion criteria applicable for EU countries (in accordance with contraindications of EU SmPC):

• Patients with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia

• Patients with severe active infection until resolution

• Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group

• Patients 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 patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• TERIFLUNOMIDE HMR1726
Pharmaceutical form:film-coated tablet Route of administration: oral

Locations

Country	Name	City	State
Austria	Investigational Site Number 040-001	Linz
Austria	Investigational Site Number 040-002	Wien
Belgium	Investigational Site Number 056006	Brasschaat
Belgium	Investigational Site Number 056001	Bruxelles
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
Canada	Investigational Site Number 124006	Cambridge
Canada	Investigational Site Number 124007	St. John
Chile	Investigational Site Number 152003	Concepcion
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152005	Santiago
Finland	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
France	Investigational Site Number 250002	Agen Cedex
France	Investigational Site Number 250003	Aix En Provence
France	Investigational Site Number 250004	Albi
France	Investigational Site Number 250005	Amiens Cedex 1
France	Investigational Site Number 250006	Bayonne
France	Investigational Site Number 250007	Bordeaux
France	Investigational Site Number 250008	Caen
France	Investigational Site Number 250009	CAHORS Cedex 9
France	Investigational Site Number 250011	Chambery
France	Investigational Site Number 250012	Colmar
France	Investigational Site Number 250001	Dijon
France	Investigational Site Number 250015	GRENOBLE cedex
France	Investigational Site Number 250017	Le Mans Cedex 9
France	Investigational Site Number 250018	Lille Cedex
France	Investigational Site Number 250019	Limoges Cedex
France	Investigational Site Number 250020	Lyon Cedex 03
France	Investigational Site Number 250021	Marseille
France	Investigational Site Number 250022	Metz-Tessy
France	Investigational Site Number 250023	Montbeliard
France	Investigational Site Number 250024	MONTPELLIER Cedex 5
France	Investigational Site Number 250025	Mulhouse
France	Investigational Site Number 250026	Nancy
France	Investigational Site Number 250027	Nantes
France	Investigational Site Number 250028	Nimes
France	Investigational Site Number 250016	PARIS Cedex 13
France	Investigational Site Number 250029	PARIS Cedex 20
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	St 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 Cedex 9
France	Investigational Site Number 250040	Valenciennes
France	Investigational Site Number 250013	VICHY Cedex
Germany	Investigational Site Number 276001	Bergisch-Gladbach
Germany	Investigational Site Number 276003	Berlin
Germany	Investigational Site Number 276004	Freiburg
Greece	Investigational Site Number 300001	Athens
Greece	Investigational Site Number 300002	Athens
Greece	Investigational Site Number 300005	Larissa
Greece	Investigational Site Number 300004	Thessaloniki
Italy	Investigational Site Number 380008	Ancona
Italy	Investigational Site Number 380009	Bari
Italy	Investigational Site Number 380002	Gallarate (VA)
Italy	Investigational Site Number 380001	Milano
Italy	Investigational Site Number 380004	Milano
Italy	Investigational Site Number 380006	Napoli
Italy	Investigational Site Number 380005	Orbassano (TO)
Norway	Investigational Site Number 578002	Bergen
Norway	Investigational Site Number 578003	Namsos
Norway	Investigational Site Number 578001	Oslo
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724010	Córdoba
Spain	Investigational Site Number 724008	Donostia
Spain	Investigational Site Number 724001	El Palmar (MURCIA)
Spain	Investigational Site Number 724004	La Coruña
Spain	Investigational Site Number 724006	Santiago de Compostela
Spain	Investigational Site Number 724007	Valencia
Spain	Investigational Site Number 724005	Valladolid
Sweden	Investigational Site Number 752001	Karlstad
Sweden	Investigational Site Number 752003	Kungsbacka
Sweden	Investigational Site Number 752002	Motala
United Kingdom	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 States	Investigational Site Number 840084	Asheville	North Carolina
United States	Investigational Site Number 840002	Atlanta	Georgia
United States	Investigational Site Number 840077	Birmingham	Alabama
United States	Investigational Site Number 840041	Bismarck	North Dakota
United States	Investigational Site Number 840097	Boulder	Colorado
United States	Investigational Site Number 840024	Bradenton	Florida
United States	Investigational Site Number 840003	Canton	Ohio
United States	Investigational Site Number 840078	Charlotte	North Carolina
United States	Investigational Site Number 840086	Chesterfield	Missouri
United States	Investigational Site Number 840089	Clearwater	Florida
United States	Investigational Site Number 840073	Clinton Township	Michigan
United States	Investigational Site Number 840055	Coconut Creek	Florida
United States	Investigational Site Number 840040	Colorado Springs	Colorado
United States	Investigational Site Number 840072	Cranston	Rhode Island
United States	Investigational Site Number 840007	Cullman	Alabama
United States	Investigational Site Number 840060	Dallas	Texas
United States	Investigational Site Number 840009	Dayton	Ohio
United States	Investigational Site Number 840046	Denver	Colorado
United States	Investigational Site Number 840100	East Setauket	New York
United States	Investigational Site Number 840016	Englewood	Colorado
United States	Investigational Site Number 840094	Fort Collins	Colorado
United States	Investigational Site Number 840012	Fort Wayne	Indiana
United States	Investigational Site Number 840107	Foxboro	Massachusetts
United States	Investigational Site Number 840049	Freehold	New Jersey
United States	Investigational Site Number 840018	Fullerton	California
United States	Investigational Site Number 840037	Fullerton	California
United States	Investigational Site Number 840068	Golden Valley	Minnesota
United States	Investigational Site Number 840098	Golden Valley	Minnesota
United States	Investigational Site Number 840020	Henderson	Nevada
United States	Investigational Site Number 840070	Henrico	Virginia
United States	Investigational Site Number 840104	Hialeah	Florida
United States	Investigational Site Number 840010	Indianapolis	Indiana
United States	Investigational Site Number 840026	Lincoln	Nebraska
United States	Investigational Site Number 840108	Long Beach	California
United States	Investigational Site Number 840034	Louisville	Kentucky
United States	Investigational Site Number 840075	Macon	Georgia
United States	Investigational Site Number 840052	Mansfield	Texas
United States	Investigational Site Number 840101	Miami Lakes	Florida
United States	Investigational Site Number 840038	Milwaukee	Wisconsin
United States	Investigational Site Number 840112	Milwaukee	Wisconsin
United States	Investigational Site Number 840053	Monaca	Pennsylvania
United States	Investigational Site Number 840079	Morgantown	West Virginia
United States	Investigational Site Number 840048	Nashville	Tennessee
United States	Investigational Site Number 840076	Neenah	Wisconsin
United States	Investigational Site Number 840005	New York	New York
United States	Investigational Site Number 840014	Newport Beach	California
United States	Investigational Site Number 840064	NY	New York
United States	Investigational Site Number 840019	Oceanside	California
United States	Investigational Site Number 840011	Ormond Beach	Florida
United States	Investigational Site Number 840056	Philadelphia	Pennsylvania
United States	Investigational Site Number 840021	Phoenix	Arkansas
United States	Investigational Site Number 840087	Phoenix	Arizona
United States	Investigational Site Number 840114	Phoenix	Arizona
United States	Investigational Site Number 840042	Raliegh	North Carolina
United States	Investigational Site Number 840109	Richmond	Virginia
United States	Investigational Site Number 840017	Roanoke	Virginia
United States	Investigational Site Number 840047	Rockport	Maine
United States	Investigational Site Number 840028	San Antonio	Texas
United States	Investigational Site Number 840105	Sanford	North Carolina
United States	Investigational Site Number 840059	Sarasota	Florida
United States	Investigational Site Number 840071	Schenectady	New York
United States	Investigational Site Number 840080	Scottsdale	Arizona
United States	Investigational Site Number 840069	Spokane	Washington
United States	Investigational Site Number 840030	Springfield	Massachusetts
United States	Investigational Site Number 840058	St. Louis	Missouri
United States	Investigational Site Number 840008	St. Petersburg	Florida
United States	Investigational Site Number 840091	Staten Island	New York
United States	Investigational Site Number 840081	Sunrise	Florida
United States	Investigational Site Number 840045	Syracuse	New York
United States	Investigational Site Number 840044	Toms River	New Jersey
United States	Investigational Site Number 840032	Tucson	Arizona
United States	Investigational Site Number 840035	Tullahoma	Tennessee
United States	Investigational Site Number 840054	Vienna	Virginia
United States	Investigational Site Number 840074	Wilmington	North Carolina
United States	Investigational Site Number 840090	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment at 48 weeks of global satisfaction with teriflunomide treatment, measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score		48 weeks	No
Secondary	Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from baseline to week 4 (W4) and to week 48 (W48) in patients switching from another Disease Modifying Therapy (DMT)		Baseline to W4 and W4 to W48	No
Secondary	Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from W4 to W48 in naïve patients		W4 to W48	No
Secondary	Change in disease progression from baseline to week 24 (W24) and to W48 of teriflunomide treatment, measured by the Patient Determined Disease Steps (PDDS)		Baseline to W48	No
Secondary	Change in disease progression from baseline to W24 and to W48 of teriflunomide treatment, measured by the Multiple Sclerosis Performance Scale (MSPS) score		Baseline to W24 and W24 to W48	No
Secondary	Clinical outcomes: treated relapses, time to first treated relapse		Over 48 weeks	No
Secondary	Change in cognition from baseline to W48 of teriflunomide treatment, measured by the Symbol Digit Modalities Test (SDMT) score		Baseline to W48	No
Secondary	Overview of adverse events (AEs) based on AE reporting at each visit		Over 48 weeks	Yes
Secondary	Adherence (ie, compliance) and persistence (ie, duration of exposure) to teriflunomide treatment		Over 48 weeks	No
Secondary	Quality of life: change from baseline to W48 of teriflunomide treatment, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) score and Stern Leisure Activity Scale		Baseline to W48	No
Secondary	Expanded Disability Status Scale (EDSS) score		At baseline and at W48	No