Trials / Completed
CompletedNCT02490982
Teriflunomide Observational Effectiveness Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teriflunomide | The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients. |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-12-01
- Completion
- 2021-06-28
- First posted
- 2015-07-07
- Last updated
- 2021-08-18
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02490982. Inclusion in this directory is not an endorsement.