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

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01895335

Run by

Sanofi

People needed

1001

Starts

2013-06-01

Expected to finish

2015-11-01

Last updated by the study team

2016-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• 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.

Where it is running

• 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 840077 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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