Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease

NCT07694674 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai 10th People's Hospital

Phase

Observational

Started

2026-01-16

Last updated

2026-07-10

Condition(s) studied

Inflamatory Bowel DiseaseCrohn Disease (CD)

Investigational drug(s) / intervention(s)

Infliximab →Adalimumab →Vedolizumab →Ustekinumab (UST) →

Infliximab: Infliximab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 5 mg/kg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.

Adalimumab: Adalimumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 160 mg subcutaneously at week 0, 80 mg at week 2, and 40 mg every 2 weeks from week 4 onward.

Vedolizumab: Vedolizumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 300 mg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.

Ustekinumab (UST): Ustekinumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen included a weight-based intravenous induction dose, followed by 90 mg subcutaneously every 8 weeks.

Study summary

This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years. * Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings. * Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection. * Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery. * Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months. * Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence. Exclusion Criteria: * Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy. * Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy. * No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment. * Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate. * Other conditions considered by the investigators to be inappropriate for inclusion.

Primary outcome measure(s)

Endoscopic recurrence rate — 6 to 12 months after surgery
The proportion of patients with endoscopic recurrence, defined as a Rutgeerts score ≥ i2 on ileocolonoscopy performed 6 to 12 months after CD-related intestinal resection.

Trial sites (1)

Facility	City	Region	Status
The Tenth People's Hospital of Shanghai	Shanghai	Shanghai Municipality	Recruiting

On this site

📄 Remicade (infliximab) drug profile → 📄 Humira (adalimumab) drug profile → 📄 Entyvio (vedolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07694674 on ClinicalTrials.gov ↗ ← All trials in China