Teriflunomide Observational Effectiveness Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Teriflunomide Observational Effectiveness Study

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Teriflunomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teriflunomide<br>Patient-reported outcomes and clinical assessment | Drug: Teriflunomide<br>* The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.<br>* Other names: Aubagio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome (PRO) scores | Change on patient-reported outcome measures, from baseline score and at each visit. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity - Composite measure | Change in the annualized relapse-rate and the Expanded Disability Status Scale (EDSS) over the two year period. | one year |