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

Korábbi kezelés

• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
• Patients initiating biological therapy for CD as part of another clinical trial or a medical need program.
• 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.

Más betegség

• 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..
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
• Patients with ulcerative colitis or inflammatory bowel disease type unclassified.
• Patients with active perianal disease.
• Patients with (an imminent risk) of a short bowel syndrome.
• Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.
• Patients with severe renal, pulmonary or cardiac disease.

Laborértékek

• 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).

Egyéb

• Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device.
• Patients not understanding Dutch, French, German or English.
• Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis.
• Patients with a colorectal stenosis.
• Patients with an ostomy.
• Ongoing alcohol or substance abuse.

• 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 18-80 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:
  • Penetrating disease as reason for ileocolonic resection
  • Previous ileocolonic resection within ten years of index surgery
  • Two or more previous ileocolonic resections
  • Active smoking
  • Biological therapy for Crohn's disease 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