Clinical Characteristics, Treatment Patterns, and Outcomes of Hospitalized Patients With Refractory Inflammatory Bowel Disease

NCT07697521 | Completed

• 1 other identifier: 2025-0553-YB-05
• Study Type: observational
• Target: 1,048
• Locations: 1 country
• Sites: 1

Brief Summary

the investigators conducted a multicenter retrospective cohort study of hospitalized patients with IBD from three tertiary referral centers in China to characterize the clinical features, treatment patterns, and outcomes of refractory IBD and to identify factors associated with refractory disease.

Conditions

Inflamatory Bowel Disease

Keywords

Refarctory inflammatory bowel disease; Clinical characteristics; Associated factors; Treatment patterns

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Clinical Remission as Assessed by CDAI or Partial Mayo Score at 12 Months

  Clinical remission will be assessed 12 months after the most recent treatment adjustment. For patients with Crohn's disease, clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than 150. For patients with ulcerative colitis, clinical remission is defined as a partial Mayo score of 1 or less. The outcome will be reported as the percentage of participants achieving clinical remission.

  1 year

• Percentage of Participants Achieving Endoscopic Remission as Assessed by SES-CD, Rutgeerts Score, or Mayo Endoscopic Subscore at 12 Months

  Endoscopic remission will be assessed among participants with available endoscopic follow-up 12 months after the most recent treatment adjustment. For Crohn's disease, endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 2 or less, or a Rutgeerts score of i1 or less in postoperative patients. For ulcerative colitis, endoscopic remission is defined as a Mayo endoscopic subscore of 1 or less. The outcome will be reported as the percentage of participants achieving endoscopic remission.

  1 year

• Percentage of Participants Undergoing IBD-related Surgery Within 12 Months After the Most Recent Treatment Adjustment

  IBD-related surgery is defined as surgery performed for inflammatory bowel disease-related complications, including intestinal obstruction, perforation, massive gastrointestinal bleeding, or medically refractory disease. The outcome will be reported as the percentage of participants who undergo IBD-related surgery within 12 months after the most recent treatment adjustment.

  1 year

Secondary Outcomes (1)

• Time to Discontinuation or Switching of Advanced Therapy

  1 year

Study Arms (1)

Refractory IBD

Other: Retrospective medical record review

Interventions

Retrospective medical record review OTHER

No intervention was assigned or implemented as part of this retrospective observational cohort study. The study involved retrospective review of routinely collected, de-identified electronic medical record data from hospitalized patients with inflammatory bowel disease. Data collected included demographic characteristics, disease phenotype, laboratory findings, treatment exposure, treatment sequence, drug persistence, and clinical outcomes.

Refractory IBD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients had an established diagnosis of CD or UC based on clinical, endoscopic, radiologic, and histopathologic findings in accordance with European Crohn's and Colitis Organization guidance. Refractory IBD was defined according to the IOIBD consensus criteria. Patients were classified as having refractory IBD if they fulfilled at least one of the following criteria: failure of at least two biologic or small-molecule therapies with different mechanisms of action; recurrence after at least two surgeries in adult patients with CD; complex perianal disease; or chronic antibiotic-refractory pouchitis. Psychological factors were not included because they could not be assessed consistently in this retrospective study. Patients were excluded if they had participated in clinical trials or received investigational drugs, had concomitant malignancy, severe immunodeficiency, or other systemic autoimmune diseases, or were diagnosed with IBD-unclassified.

You may qualify if:

• Eligible patients had an established diagnosis of CD or UC based on clinical, endoscopic, radiologic, and histopathologic findings in accordance with European Crohn's and Colitis Organization guidance

You may not qualify if:

• Patients were excluded if they had participated in clinical trials or received investigational drugs, had concomitant malignancy, severe immunodeficiency, or other systemic autoimmune diseases, or were diagnosed with IBD-unclassified

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

The Tenth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 201505, China

Location

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: June 29, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)