Management of moderate POstoperative recurrence in Crohn's disease: a randoMizEd contROLled trial of therapeutic escalation, the POMEROL trial

Phase 1

Recruiting

• Conditions: Crohn's disease; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-508242-18-00
• Lead Sponsor: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-19
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Age: = 18 years, < or = 75 years, Diagnosis of Crohn's disease according to usual criteria, Intestinal resection with ileocolonic anastomosis removing all Crohn’s disease inflammatory lesions performed within the last 6-12 months (patients who underwent a two stage surgical procedure are also eligible if the endoscopic evaluation is performed 6-12 months after restoration of the fecal stream), Postoperative endoscopy performed between 6 and 12 months +/- 2 months after ileocolonic anastomosis reaching the neoterminal ileum, Postoperative endoscopic recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading

Exclusion Criteria

Patients with an ostomy, Patients with active perianal Crohn's disease, Patients with a contraindication to infliximab: cancer in the 5 years prior to inclusion, excluding non-melanoma skin cancer, active tuberculosis or untreated latent tuberculosis, moderate or severe heart failure, HIV or HBV infection (serology < 3 months), recent live vaccination (within 4 weeks of inclusion visit)., Pregnant women, Patients under legal protection or unable to express their consent., Patients not affiliated to a health insurance system., Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research., Patients with ulcerative colitis or IBD type unclassified, Patients with an ileorectal or ileal pouch-anal anastomosis, Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions or at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies, Patients with symptoms of active CD, defined as average daily SF = 3.5 and average daily AP score = 1.5, having started after a free interval without symptoms of one month after surgery, Patients with obstructive symptoms of CD defined by a CDOS > 4 (20) (see Appendix for description of the score). Asymptomatic patients receiving an endoscopic dilatation for a non-passable stenosis at screening endoscopy in centres where it is a current practice to estimate the lesions extent can be included., Patients treated with any biological therapy (except for intraocular injections) or an investigational medical product after index surgery, Patients having started thiopurines or methotrexate more than 6 weeks after ileocolonic anastomosis with restoration of the faecal stream, Patients in whom not all inflammatory lesions have been removed at index surgery: e.g. incomplete ileo-colonic resections, active colitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified