Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 23
- 主要终点
- NEDA-2
研究概览
简要总结
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
- •Age between 18 - 55 years at the time of index.
- •No evidence of prior disease modifying therapy for MS.
- •Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.
- •Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.
- •Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.
排除标准
- •Pregnant at any time during the study observation period.
- •Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
- •Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).
- •Phase III registrational trial patients
研究组 & 干预措施
Rebif - early discontinuation cohort - tolerability
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability
干预措施: Rebif (Drug)
Rebif - 1 year MRI cohort
Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months
干预措施: Rebif (Drug)
Rebif - 1 year clinical cohort
Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline
干预措施: Rebif (Drug)
Rebif - early discontinuation cohort - adverse events
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events
干预措施: Rebif (Drug)
Rebif - early discontinuation cohort - disease activity
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity
干预措施: Rebif (Drug)
Tecfidera - 1 year MRI cohort
Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months
干预措施: Tecfidera (Drug)
Tecfidera - 1 year clinical cohort
Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline
干预措施: Tecfidera (Drug)
Tecfidera - early discontinuation cohort - tolerability
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability
干预措施: Tecfidera (Drug)
Tecfidera - early discontinuation cohort - adverse events
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events
干预措施: Tecfidera (Drug)
Tecfidera - early discontinuation cohort - disease activity
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity
干预措施: Tecfidera (Drug)
结局指标
主要结局
NEDA-2
时间窗: 12 months
Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients. No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.
次要结局
- Neurological differences between two treatment groups(12 months)
- Proportion of individuals within each treatment group who discontinued, stratified by reason(12 months)
- Clinical differences between the two treatment groups(12 months)