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

NCT07694674 | Recruiting

• 1 other identifier: SHSY-IEC-6.0/26K14/P01
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflamatory Bowel Disease; Crohn Disease (CD)

Keywords

Crohn's disease; biologics; postoperative; recurrence; efficacy

Outcome Measures

Primary Outcomes (1)

• Endoscopic recurrence rate

  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.

  6 to 12 months after surgery

Secondary Outcomes (6)

• Severe endoscopic recurrence rate

  6 to 12 months after surgery

• Clinical recurrence rate

  Up to 5 years after surgery

• Long-term endoscopic recurrence rate

  3 and 5 years after surgery

• Crohn's disease-related rehospitalization rate

  Up to 5 years after surgery

• Crohn's disease-related reoperation rate

  Up to 5 years after surgery

Study Arms (2)

Postoperative anti-TNF biologics group

Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.

Biological: Infliximab; Biological: Adalimumab

Postoperative non-anti-TNF biologics group

Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.

Biological: Vedolizumab; Biological: Ustekinumab (UST)

Interventions

Infliximab BIOLOGICAL

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.

Postoperative anti-TNF biologics group

Adalimumab BIOLOGICAL

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.

Postoperative anti-TNF biologics group

Vedolizumab BIOLOGICAL

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.

Postoperative non-anti-TNF biologics group

Ustekinumab (UST) BIOLOGICAL

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.

Postoperative non-anti-TNF biologics group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025. Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation. Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

The Tenth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 201505, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Recurrence

Interventions

Infliximab; Adalimumab; vedolizumab; Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)