Cure8 trial brief
This trial tests whether initiating infliximab after surgery for patients with moderate endoscopic recurrence can prevent progression and avoid repeat surgery or worse endoscopic scores. Results could affect post-operative management decisions for Crohn’s patients with early recurrence.
Adult Crohn’s patients after ileocolonic resection (especially those with Rutgeerts i2), clinicians managing postoperative Crohn’s care, patients considering biologic escalation post-surgery, and researchers studying postoperative recurrence prevention.
This ClinicalTrials.gov record describes the POMEROL randomized trial testing whether starting infliximab-CT-P13 (an infliximab biosimilar) for patients with moderate endoscopic postoperative recurrence (Rutgeerts i2) after ileocolonic resection reduces endoscopic recurrence at 12 months compared with a status-quo strategy.
The trial randomized patients 6–12 months after ileocolonic anastomosis who had a centrally confirmed i2 Rutgeerts score. The escalation arm protocol starts infliximab CT-P13 with IV infusions at weeks 0 and 2 (5 mg/kg) then subcutaneous 120 mg every 2 weeks from week 6.
The comparator arm continues any existing prophylactic therapy or starts no new treatment if none was given. Primary outcome is the proportion with an i0–i1 modified Rutgeerts score at 12 months.
Secondary outcomes include higher-grade endoscopic recurrence (i3–i4), clinical recurrence definitions incorporating PRO2, CRP and fecal calprotectin increases, surgical recurrence, need for endoscopic dilation, time to recurrence, safety, quality of life, and work productivity.
The registry entry describes study design, dosing, and endpoints but does not report trial findings in this record. The trial uses objective endoscopic scoring (modified Rutgeerts) with central blinded reading and includes biomarker and clinical endpoints; interpretation requires the trial’s outcome data and safety reporting.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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