A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,019
- 试验地点
- 154
- 主要终点
- Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3
研究概览
简要总结
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.
Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide.
Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices.
- •Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care.
- •Participants prescribed risankizumab in accordance with the approved local label.
- •Participants able to understand and communicate with the investigator and comply with the requirements of the study.
- •Participants willing and able to provide authorization to use and disclose personal health information.
- •Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).
排除标准
- •Females who are pregnant or breast feeding at baseline.
- •Participants with any contraindication to risankizumab.
- •Participants previously exposed to risankizumab.
- •Participants currently participating in an interventional clinical trial.
结局指标
主要结局
Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3
时间窗: At Month 12
Clinical Remission is defined as HBI \<= 4. Clinical Response is defined as HBI reduction \>= 3 points. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient-reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores \< 5 indicate clinical remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease.
次要结局
未报告次要终点