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Recruiting Phase 4

Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy

NCT05169593 · tracked via the Priya Life Science Italy tracker
Phase
Phase 4
Started
2022-09-08
Last updated
2026-05-05

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Biological Drug →

Biological Drug: Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence

Study summary

With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited.

Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology 3. Males and females 18-80 years old. 4. 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. 5. Patients having an increased risk for postoperative recurrence for any of the following reasons: 1. Penetrating disease as reason for ileocolonic resection 2. Previous ileocolonic resection within ten years of index surgery 3. Two or more previous ileocolonic resections 4. Active smoking 5. Biological therapy for Crohn's disease within 3 months of index ileocolonic resection 6. Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed. 7. 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. 8. Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization Exclusion Criteria: 1. Participant has a history of primary non response or secondary loss of response to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab.. 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial. 4. Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device. 5. Patients initiating biological therapy for CD as part of another clinical trial or a medical need program. 6. Patients not understanding Dutch, French, German or English. 7. Patients with ulcerative colitis or inflammatory bowel disease type unclassified. 8. Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis. 9. Patients with active perianal disease. 10. Patients with a colorectal stenosis. 11. Patients with an ostomy. 12. Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than ten days after ileocolonic resection or restoration of the faecal stream. 13. Patients with (an imminent risk) of a short bowel syndrome. 14. Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation. 15. Patients with liver test abnormalities (aspartate transaminase, alanine transaminase, alkaline phosphatases, or bilirubin \> 2 upper limit of normal), leukopenia (\<3000 white blood cells 109/L, \<1500 neutrophils 109/L ), thrombocytopenia (platelets \< 50.000/mm3). 16. Patients with severe renal, pulmonary or cardiac disease. 17. Ongoing alcohol or substance abuse.

Primary outcome measure(s)

  • postoperative endoscopic recurrence (Rutgeerts score ≥i2b) — 86 weeks
    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
  • need for unscheduled treatment adaptation prior to week 86 — 86 weeks
    When, due to clinical symptoms, therapy needs to be started or switched prior to week 86

Trial sites (28)

FacilityCityRegionStatus
ZAS Antwerp Antwerpen Recruiting
UZA Edegem Antwerpen Recruiting
Erasmus ziekenhuis Brussels Brussels Capital Recruiting
Cliniques Universitaires Saint Luc Brussels Brussels Capital Recruiting
UZ Brussel Jette Brussels Capital Recruiting
CHwapi Tournai Henegouwen Recruiting
ZOL Genk Genk Limburg Recruiting
CHC Montlégia Liège Liège Recruiting
CHU de Liège Liège Liège Recruiting
CHU UCL Namur site Godinne Yvoir Namur Not Yet Recruiting
AZ Maria Middelares Ghent Oost-Vlaanderen Recruiting
UZ Gent Ghent Oost-Vlaanderen Recruiting
UZ Leuven Leuven Vlaams-Brabant Recruiting
Sint lucas Brugge Bruges West-Vlaanderen Not Yet Recruiting
AZ Damiaan Ostend West-Vlaanderen Recruiting
OLV Aalst Aalst Belgium Recruiting
Imeldaziekenhuis Bonheiden Belgium Recruiting
AZ Klina Brasschaat Belgium Recruiting
AZ Sint-Jan Bruges Belgium Recruiting
AZ Sint Lucas Ghent Belgium Recruiting
Jessa ziekenhuis Hasselt Belgium Recruiting
AZ Sint Maarten Mechelen Belgium Withdrawn
AZ Delta Roeselare Belgium Recruiting
Vitaz Sint-Niklaas Belgium Recruiting
Humanitas research hospital Milan Rozzano MI Not Yet Recruiting
IRCCS De Bellis Castellana Grotte Castellana Grotte Italy Recruiting
Careggi University Hospital Florence Italy Recruiting
IRCCS San Raffael Hospital Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05169593 on ClinicalTrials.gov ↗ ← All trials in Italy