Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)

• Status: Not yet recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Study type : A 30 months, multicentre, open-label strategic randomized controlled trial

Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection).

Treatments :

Stratification at inclusion according to prophylactic therapy.

Patients randomized in 2 arms:

• Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose.

• Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.

Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Collaborator: Celltrion
• Treatments: Infliximab; Methotrexate

Criteria

Inclusion Criteria:

• Crohn's disease diagnosed according usual criteria

• Bowel resection with ileocolonic anastomosis performed removing all inflammatory lesions

• Postoperative endoscopy performed between 6 and 12 months after ileocolonic anastomosis reaching the neoterminal ileum (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)

• Moderate endoscopic postoperative recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading

Exclusion Criteria:

• Patients with an ostomy

• Ulcerative colitis or IBD type unclassified

• Ileorectal or ileal pouch-anal anastomosis GETAID_2021-01_POMEROL_protocol_20210714_v1.2 6

• Symptoms defined as average daily SF ≥ 3.5 and average daily AP score ≥ 1.5 having started after a free interval without symptoms of at least one month after surgery

• Patients with obstructive symptoms of CD defined by a CDOS > 4

• Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies

• Patients treated with 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 fecal stream

• Patients in whom not all inflammatory lesions have been removed at index surgery

• 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 < 6 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.