Comparing biologic medicines for stopping Crohn's disease from returning after bowel surgery
Compares infliximab, adalimumab, vedolizumab and ustekinumab in adults after Crohn's disease bowel surgery.
Plain-language title generated from the registry record
Registry title: Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07694674, who can take part
Where in China
- The Tenth People's Hospital of ShanghaiShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai 10th People's Hospital
- Trial code
- NCT07694674
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
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.
Inclusion: 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: 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; 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; 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.