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Comparing two methods of biological therapy to prevent Crohn's disease recurrence after surgery

Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease

Phase 4 Interventional Universitaire Ziekenhuizen KU Leuven · NCT05169593

This study is testing whether a new way of giving biological therapy during endoscopy can help prevent Crohn's disease from coming back after surgery, compared to the usual method, for people who have had their intestines operated on.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment292 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorUniversitaire Ziekenhuizen KU Leuven Academic / other
Drugs / interventionsadalimumab, infliximab, ustekinumab, vedolizumab, risankizumab
Locations28 sites (Antwerp, Antwerpen and 27 other locations)
Trial IDNCT05169593 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of an endoscopy-driven approach versus a systematic introduction of biological therapy in preventing postoperative endoscopic recurrence in patients with Crohn's disease who have undergone ileocolonic resection. It is a prospective, randomized, multicentre, parallel group trial that aims to determine if the endoscopy-driven method is non-inferior to the systematic approach at week 86 post-surgery. Secondary analyses will assess clinical, biological, and surgical recurrence, as well as quality of life and cost-effectiveness. The study also aims to develop a new scoring system for evaluating postoperative endoscopic recurrence using endoscopic images.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of Crohn's disease who have recently undergone ileocolonic resection.

Not a fit: Patients who have previously experienced immunogenicity issues with certain biological therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more personalized and cost-effective management of Crohn's disease after surgery.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in tailoring biological therapy based on endoscopic findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Antwerp, Antwerpen and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn Diseasebiological therapyileocolonoscopyileocolonic resectionileocolonic anastomosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.