Teriflunomide Observational Effectiveness Study

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Teriflunomide

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02490982

CE15.016

Details and patient eligibility

About

The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic.

Full description

Consenting adult RRMS patients, meeting all inclusion criteria and who have been prescribed Teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (QoL), fatigue, and employment.

The study will include 300 participants from three Multiple Sclerosis (MS) Clinics. Disease and magnetic resonance imaging (MRI) activity, blood tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), complete blood count (CBC)), drug compliance, side effects, toxicity, will be monitored.

MS patients never treated with a disease modifying drug (DMD) and MS patients previously exposed to another DMD will be included. Some would have been on a single medication, while others would have been treated with two or more medications.

The results of the study will provide the patient-perceived global impacts of Teriflunomide on the patient's overall quality of life.

These results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consenting Relapsing Remitting Multiple Sclerosis adults with an Expanded Disability Status Scale (EDSS) score ≤ 5.0 who have been prescribed Teriflunomide and who agree to follow study procedures.

Exclusion criteria

• Primary progressive or secondary progressive Multiple Sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.

Trial design

106 participants in 1 patient group

Teriflunomide

Description:

Patient-reported outcomes and clinical assessment

Treatment:

Drug: Teriflunomide