Relapsing Remitting Multiple Sclerosis
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGTeriflunomide
The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.
Sponsors
Genzyme, a Sanofi Company
Montreal Neurological Institute and Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome (PRO) scores | one year | Change on patient-reported outcome measures, from baseline score and at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity - Composite measure | one year | Change in the annualized relapse-rate and the Expanded Disability Status Scale (EDSS) over the two year period. |
Countries
Canada
Outcome results
None listed