Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Steroid-free deep remission of IBD
研究概览
简要总结
Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:
- Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included.
- Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System.
Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months.
Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.
详细描述
Multicenter, ambispectic observational study with drug
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
- •Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).
- •Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.
- •Written informed consent certifying the willingness of the subject to participate to the study.
排除标准
- •Age < 18 years.
- •Patients with diagnosis of indeterminate colitis.
- •Patients naive to advanced (biological or small molecule) therapy for IBD.
- •Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.
结局指标
主要结局
Steroid-free deep remission of IBD
时间窗: 24 months
To evaluate the percentage of patients achieving the steroid-free deep remission of UC and CD after 12 months of different II line therapy (second sequential biological/advanced therapy).
次要结局
未报告次要终点