A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
- 试验地点
- 37
- 主要终点
- Natural history of Inflammatory Bowel Disease: Treatment response
研究概览
简要总结
TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
- •Have plans for future visits at the site for continued management of IBD.
排除标准
- •Inability to provide written informed consent/assent.
- •Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
- •Prior total abdominal colectomy for UC or IBDU.
结局指标
主要结局
Natural history of Inflammatory Bowel Disease: Treatment response
时间窗: Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics
时间窗: Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use
时间窗: Up to 5 years
Natural history of Inflammatory Bowel Disease: Characteristics of IBD
时间窗: Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression
时间窗: Up to 5 years
次要结局
- Self-reported patient health measures: EQ-5D(Every 3 months for 5 years)
- Self-reported patient health measures: PRO-2 for Crohn's Disease(Every 3 months for 5 years)
- Reasons for treatment discontinuation(Up to 5 years)
- Self-reported patient health measures: PRO-2 for Ulcerative colitis(Every 3 months for 5 years)
- Self-reported patient health measures: Manitoba IBD Index (MIBDI)(Every 3 months for 5 years)
- Timepoint of endoscopic response(Up to 5 years)
- Self-reported patient health measures: 2-question Adherence Measure(Every 3 months for 5 years)
- Timepoint of endoscopic remission(Up to 5 years)
- Endoscopic measures of mucosal healing(Up to 5 years)
- Adverse event frequency and severity(Every 3 months for 5 years)
- Timepoint of clinical response(Every 3 months for 5 years)
- Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)(Every 3 months for 5 years)