Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Percentage of Participants Managed Using Treat-to-Target (T2T)
研究概览
简要总结
Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, relapsing, and often disabling condition characterized by inflammation of the gastrointestinal tract. A treat-to-target strategy (T2T) is recommended by international guidelines to optimize long-term outcomes in IBD. The purpose of this study is to describe the real-life implementation of T2T in IBD worldwide and the association between using a T2T strategy and disease outcomes.
This is a multi-country, observational, retrospective (non-interventional) study with a cross-sectional component based upon a sample of adult participants with IBD. All objectives will be assessed for IBD and then for CD/UC separately. Primary and secondary objectives will be assessed for the overall population over the 24 months study period.
As this is an observational study, enrolled participants will be managed and followed up according to the standard practice.
Retrospective chart review over the 24-months from date of inclusion will allow us to collect the variables of interest by using an e-CRF. There will be no additional burden for participants in this trial. Study visits will not be required as this is a retrospective chart review.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female participants (>= 18 years old) at the inclusion date who present within the usual course of care
- •Participants able to provide voluntary informed consent prior to any study data collection
- •Participant diagnosed with Crohn's Disease (CD) or Ulcerative Colitis (UC) for at least 24 months at the inclusion date
- •With >= 24 months of available medical records from the inclusion date
排除标准
- •Participants who had received treatment with any investigational drug/device/intervention over the past 24 months prior to the enrolment
- •Participants under legal protection
- •History of proctocolectomy
研究组 & 干预措施
Adults with Inflammatory Bowel Disease
Participants will be managed and followed according to the standard practice.
结局指标
主要结局
Percentage of Participants Managed Using Treat-to-Target (T2T)
时间窗: 12 Weeks
Defined as a participant with a therapeutic modification \[dose escalation, change in therapy\] within 12 weeks following any objective disease monitoring that demonstrated active disease.
次要结局
未报告次要终点