CTIS2022-500311-39-00
Recruiting
Phase 1
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 sites352 target enrollmentStarted: March 4, 2022Last updated:
ConditionsPatients with Crohn's disease undergoing surgery and having at least one risk factor for postoperative recurrence of the disease.MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Z Leuven
- Enrollment
- 352
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Similar Trials
Completed
Not Applicable
Phase II study on prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by placement of 4Fr prophylactic pancreatic duct stent in patients who is performed endoscopic pancreatic duct injection (multicenter study)JPRN-UMIN000031972Wakayama Medical University250
Not yet recruiting
Not Applicable
Prevention of Post-colon ESD Coagulation Syndrome using Polysaccharide Hemostatic PowderNeoplasmsKCT0008728Soon Chun Hyang University Hospital Cheonan196
Recruiting
Phase 4
Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological TherapyCrohn DiseaseNCT05169593Universitaire Ziekenhuizen KU Leuven292
Completed
Not Applicable
The late follow-up endoscopy as bleeding prevention after the gastric endoscopic submucosal dissection in the patient with thienopyridine derivative or low-dose aspirin and warfarin combinatioGastric adenoma or early gastric cancer(cStage IA)JPRN-UMIN000016475Japan Gastroenterological Endoscopy Society Hokuriku Chapter150
Completed
Phase 4
Prevention of pancreatic inflammation after endoscopy of the pancreas and bile duct with anti-inflammatoryRBR-6zkm5kJulio Carlos Pereira Lima