The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- To stratify patients at diagnosis into high and low- risk cohorts
研究概览
简要总结
A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.
详细描述
This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active UC or CD with typical symptoms in conjunction with at least one objective measure of disease activity: elevated CRP, calprotectin, endoscopic evidence.
- •Not currently receiving systemic therapy* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose.
- •Due to be managed using a "step-up" or "accelerated step-up" approach (so will not receive biologics as first line therapy).
- •Aged 16-80 years old.
- •Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve.
排除标准
- •The presence of any of the following will preclude patient inclusion:
- •Patients with fistulating peri-anal Crohn's disease or active perianal sepsis.
- •Obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy.
- •Patients who are scheduled to start on "top-down" therapy or receive biologics as a first line therapy
结局指标
主要结局
To stratify patients at diagnosis into high and low- risk cohorts
时间窗: 12 month follow up
Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.
次要结局
未报告次要终点