A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 86
- 主要终点
- Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
研究概览
简要总结
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
详细描述
The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™.
The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
- •Has agreed to use the CDPATH™ tool.
- •Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.
排除标准
- •Has had known complications from CD including but not limited to: bowel stricture, CD-related intra-abdominal abscess, internal penetrating disease (known fistula other than perianal fistula), non-perianal surgery, bowel resection, or stricturoplasty. A perianal fistula or abscess without other signs of penetrating disease is allowed.
- •Has had any non-CD-related abdominal surgery.
- •Has received investigational biologic or nonbiologic agents for the treatment of CD in an investigational protocol. Approved biologic or nonbiologic agents for CD are allowed.
- •Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.
研究组 & 干预措施
CDPATH™
Participants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis.
干预措施: CDPATH™ (Other)
CDPATH™
Participants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis.
干预措施: Blood Draw (Other)
结局指标
主要结局
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
时间窗: Baseline (Day 1)
The risk profile of an individual participant with CD is the output of the CDPATH™ tool. Categories for CD includes low, medium, high risk of developing a CD complication within 3 years.
次要结局
- Change From Baseline in Decisional Conflict Scale (DCS) Score(Baseline, then every 6 months up to 36 months)
- Percentage of Participants with Healthcare Resource Utilization(Up to 36 months)
- Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category(Up to 36 months)
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score(Baseline, then every 6 months up to 36 months)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score(Baseline, then every 6 months up to 36 months)
- Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool(Up to 36 months)
- Number of Participants with Clinical Outcomes(Up to 36 months)
- Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool(First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months))