Teriflunomide Observational Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Patient-reported outcome (PRO) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Teriflunomide
Patient-reported outcomes and clinical assessment
干预措施: Teriflunomide (Drug)
结局指标
主要结局
Patient-reported outcome (PRO) scores
时间窗: one year
Change on patient-reported outcome measures, from baseline score and at each visit.
次要结局
- Disease activity - Composite measure(one year)
研究者
Pierre Duquette
MD
Centre hospitalier de l'Université de Montréal (CHUM)