An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Endoscopic recurrence rate at Wk 24
研究概览
简要总结
The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.
详细描述
This is an open-labeled, single arm, non-interventional, prospective, descriptive study, planned to include postoperative CD patients. After ileocolonic surgical resection, the patients who are treated with GUS will be enrolled in this study. The period is 48 weeks. The primary endpoint is Endoscopic recurrence （modified Rutgeerts score ≥ i2b）at Wk 24. IA is planned to be conducted when 30% of the enrolled patients have finished 24wk follow up. The Secondary endpoint are Clinical remission without recurrence（CDAI < 150）at Wk24/Wk48;Endoscopic recurrence at Wk48 (modified Rutgeerts score ≥ i2b);Endoscopic remission（SES-CD≤3）at Wk24/48;Safety profile. Exploratory endpoint includes histologic score (Geboes scale/RHI/GHAS) at Wk24/48 ileocolonoscopy; time to endoscopic recurrence; time to recurrence of symptoms; endoscopic recurrence rate at Wk24/48(POCER)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients≥ 18，
- •Have a documented diagnosis of moderate to severe CD
- •Have undergone an ileocolonic surgical resection
排除标准
- •Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess
- •Active infection
- •Currently has a malignancy or has a history of malignancy within 5 years
研究组 & 干预措施
Gulselkumab after surgery
The target population is male or female participants (minimum age 18) with a diagnosis of CD who have had a qualifying surgery (eg, ileocolonic resection) at most 3months before enrolled. Participants will be excluded if they have a short segment of bowel affected (ie,less than 10 cm) for fibrostenotic disease and they had their first surgery more than 10 years after diagnosis of CD. There is no requirement that participants have failed prior biologics.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Endoscopic recurrence rate at Wk 24
时间窗: From enrollment to Week 24
The primary objective of this study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of CD in participants after surgery
次要结局
- Clinical remission without recurrence at Wk24/Wk48(From enrollment to Wk48)
- Endoscopic recurrence at Wk48(From enrollment to Wk48)
- Endoscopic remission at Wk24/48(From enrollment to Wk48)
- Safety profile(From enrollment to Wk48)
研究者
Xiaolei Wang
Chief Physician
Shanghai 10th People's Hospital