CTIS2022-500311-39-00招募中1 期
Prevention of postoperative endoscopic recurrence with endoscopy-driven versus systematic biological therapy: a randomized, multicentre, parallel group pragmatic non-inferiority trial in adult patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis - S62015
Z Leuven0 个研究点目标入组 352 人开始时间: 2022年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 352
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures., Patients with a diagnosis of Crohn’s disease based on radiology, endoscopy and/or histology., Males and females =18 years old., Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit., Patients having an increased risk for postoperative recurrence for any of the following reasons: a) Penetrating disease as reason for ileocolonic resection; b) Previous ileocolonic resection within ten years of index surgery; c)Two or more previous ileocolonic resections aside from the index ileocolonic resection; d) Active smoking (i.e. smoked at least 7 sigarets during the past month); e) Advanced therapy (including biological therapy and small molecules) within 3 months of index ileocolonic resection., Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed., Patients previously failing at least three months of steroids and/or three months of immunosuppressive therapy, or showing intolerance or a real contraindication for any of these therapies., Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization.
排除标准
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol., Patients with a colorectal stenosis., Patients with an ostomy., Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than 15 days after ileocolonic resection or restoration of the faecal stream., Patients with (an imminent risk) of a short bowel syndrome., Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation., Participant has a history of primary non-response, secondary loss of response, intolerance or contraindication to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab., Any other factors that might jeopardise the participant’s safety or integrity of the trial (e.g. non-compliant patients)., Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial., Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device., Patients initiating biological therapy for CD as part of another clinical trial or a medical need program., Patients not understanding Dutch, French, German, Italian or English., Patients with ulcerative colitis or inflammatory bowel disease type unclassified., Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis., Patients with active perianal disease., Females who are pregnant or nursing at the moment of Screening.
研究者
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