Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 12-week clinical response and 52-week endoscopic response
研究概览
简要总结
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-80 years with confirmed diagnosis of IBD;
- •Meeting the definition of refractory IBD (
- •Failure of at least two biologics with different mechanisms of action;
- •Crohn's disease with recurrence after two or more intestinal resections;
- •Complex perianal disease despite treatments 1 and 2);
- •Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);
- •Signed informed consent.
排除标准
- •Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;
- •History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia;
- •Prior intolerance to JAK inhibitors or IL-23 inhibitors.
结局指标
主要结局
12-week clinical response and 52-week endoscopic response
时间窗: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).
次要结局
未报告次要终点