Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 152
- 试验地点
- 60
- 主要终点
- Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.
研究概览
简要总结
This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice
详细描述
TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.
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
- •Patients of 18 years old or above
- •Patients with confirmed diagnosis of moderate to severe ulcerative colitis
- •Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC
- •Patients informed about the study procedures and receiving an information letter signed by the investigator
排除标准
- •Patients who have already received tofacitinib treatment before baseline
- •Patients that fulfill any of the contrindications according to the latest version of the SmPC
研究组 & 干预措施
Patients prescribed tofacitinib
Patients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC).
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.
时间窗: Week 52
The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period. Clinical benefit at year is defined on the basis of symptomatic remission evaluated with the PRO2 score ≤1 (absence of rectal bleeding and a stool frequency score between 0 and 1)\*. Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used oal corticosteroids for UC, (regardless of the treatment duration) during the 3 months preceding the end of the observation period. The clinical benefit of tofacitinib is independent of the administration or not of 5-ASA, or corticosteroids (not complying with the above definition) during the observation period (between 0 and 1 year).
次要结局
- Proportion of patients with clinical benefit of tofacitinib at 2 years(week 104)
- Predictors of the clinical benefit at one year identified from the available baseline data(Week 52)
- Proportion of patients in clinical remission and still receiving tofacitinib(Week 52 and Week 104)
- Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC)(Week 52 and week 104)
- Proportion of patients with short-term clinical response for patients still treated with tofacitinib(Approximately week 8 and 16)
- Proportion of patients with biological response during the observation period(Week 52 and 104)
- Proportion of patients with endoscopic improvement during the observation period(Week 52 and 104)
- Proportion of patients in sustained clinical remission(Week 52 and 104)
- Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy(14 days)
- Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years(Week 52, Week 52 to week 104 and week 104)
- Change in adherence to tofacitinib treatment during each visit(Week 8, 16, 24, 72, 52, 104)
- Proportion of patients with serious and non-serious adverse events.(Week 8, 16, 24,72,52 and 104)
- Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction(Week 8, 16, 24, 72, 52 and 104)
- Proportion of patients with extraintestinal manifestations at each visit(Week 8, 16, 24, 72, 52, 104)
- Proportion of patients with a colectomy during study follow-up and time of occurrence(Week 8, 16, 24, 72,52 and 104)
- Characteristics of patients and UC, on the basis of all the data collected at baseline(Week 104)