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

Prior treatment

• 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).
• 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 in whom not all inflammatory lesions have been removed at index surgery: e.g. incomplete ileo-colonic resections, active colitis.

Other illness

• Patients with active perianal Crohn's disease
• 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

Other

• Patients with an ostomy
• 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 having started thiopurines or methotrexate more than 6 weeks after ileocolonic anastomosis with restoration of the faecal stream

• 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