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

Phase 1

• Conditions: Crohn's disease patients having an i2 endoscopic postoperative recurrence 6-12 months after ileocolonic anastomosis.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-002369-17-FR
• Lead Sponsor: GETAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

-Age > 18 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
-The patient is willing to start infliximab CT-P13 at a fixed schedule of 2 intravenous infusions at week 0 and week 2 followed by subcutaneous CT-P13 every other week from week 6 onwards

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with an ostomy
-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 (15) (see Appendix for description of the score). Asymptomatic patients receiving an endoscopic dilatation for a non-passable stenosis at baseline 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.
-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 baseline).
-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.

Study & Design

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