2022-500311-39-00招募中4 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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 352
- 试验地点
- 28
- 主要终点
- Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86 or need for unscheduled treatment adaptation prior to week 86.
研究概览
简要总结
To compare the postoperative endoscopic recurrence rate in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy
研究设计
- 分配方式
- Randomized
- 主要目的
- Systematic Biological Therapy Versus Endoscopy-driven Biological Therapy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86 or need for unscheduled treatment adaptation prior to week 86.
Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86 or need for unscheduled treatment adaptation prior to week 86.
次要结局
- Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86.
- Harvey-Bradshow index (HBI) based clinical recurrence prior to week 86.
- Direct costs from Baseline to week 86.
- Need for a new ileocolonic resection prior to week 86.
- Severe adverse reactions to biological therapy prior to week 86.
- Serious adverse events prior to week 86.
- Quality of life (EQ-5D 5L) at week 30, week 62 and week 86 in comparison to Baseline.
- Crohn’s disease activity index (CDAI) based clinical recurrence at week 86.
- CDAI based clinical recurrence prior to week 86.
- Time to CDAI based clinical recurrence.
- HBI based clinical recurrence at week 86.
- Time to HBI based clinical recurrence.
- PRO-2 based clinical recurrence at week 86.
- PRO-2 based clinical recurrence prior to week 86.
- Time to PRO-2 clinical recurrence.
- Endoscopic disease activity (≥i3, ≥i2a, or ≥i1) at week 86.
- Endoscopic recurrence at week 30 (updated Rutgeerts score ≥i2b).
- Endoscopic disease activity (≥i3, ≥i2a, or ≥i1) at week 30
- Persistent endoscopic recurrence at week 86 after development of endoscopic recurrence at week 30.
- Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 86.
- Work productivity and activity impairment (WPAI:CD) at week 30, week 62 and week 86 in comparison to Baseline.
- Change in medical therapy for Crohn’s disease prior to week 86.
- Change in C-reactive protein (CRP) at week 14, week 30, week 46, week 62, and week 86 in comparison to Baseline.
- Change in faecal calprotectin at week 14, week 30, week 46, week 62, and week 86 in comparison to Baseline.
- Number of unscheduled visits related to CD (clinical visit, endoscopic or radiological evaluation).
- Suspected unexpected serious adverse reactions prior to week 86.
- Predictors of clinical, biological, endoscopic, and surgical outcome prior to week 86.
- Evolution of CDAI, HBI and PRO-2 at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of EQ-5D 5L at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of WPAI:CD at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of CRP at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of faecal calprotectin at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Change in medical therapy for Crohn’s disease prior to week 138, 190 and 242.
- Need for a new ileocolonic resection prior to week 138, 190 and 242.
- Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 138, 190 and 242.
- Severe adverse reactions to biological therapy prior to week 138, 190 and 242
- Serious adverse events prior to week 138, 190 and 242.
- Suspected unexpected serious adverse reactions prior to week 138, 190 and 242
- Predictors of clinical, biological, endoscopic, and surgical outcome prior to week 138, 190 and 242.
研究者
Marc Ferrante
Scientific
UZ Leuven
研究点 (28)
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