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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zas
  Antwerp, Antwerpen, Belgium Recruiting
• Uza
  Edegem, Antwerpen, Belgium Recruiting
• Erasmus ziekenhuis
  Brussels, Brussels Capital, Belgium Recruiting
• Cliniques Universitaires Saint Luc
  Brussels, Brussels Capital, Belgium Recruiting
• UZ Brussel
  Jette, Brussels Capital, Belgium Recruiting
• CHwapi
  Tournai, Henegouwen, Belgium Recruiting

Study contacts

• Principal investigator: Marc Ferrante, Professor — IG/MAAG-DARM-LEVER, UZ Leuven, campus Gasthuisberg, Herestraat 49 3000 Leuven
• Study coordinator: Marc Ferrante, Professor
• Email: marc.ferrante@uzleuven.be
• Phone: 016 342845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.