Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science

Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. And Ustekinumab, a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23, is a newly targeted drug approved for the treatment of Crohn's disease in recent years.Based on the high-throughput imaging characteristic analysis technique, this study quantitatively analyzed the transmural inflammation of Crohn's disease, and discussed its prognostic value in the treatment of Ustekinumab, and further analyzed the increment of its relative clinical index.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Biologics

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 501655
      • The sixth affiliated hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

January 2020 to June 2022 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University, who were treated with Ustekinumab.

Description

Inclusion Criteria:

• Inpatients with Crohn's disease diagnosed in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University from January 2020 to June 2022
• Treated with Ustekinumab and followed up regularly for 20 weeks
• Complete pre-treatment cross-sectional imaging data (CTE/MRE and US)

Exclusion Criteria:

• The diagnosis is not clear
• Under the age of 18
• Lack of endoscopic and pathological data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CD patients who received Ustekinumab treatment; 1. Inpatients with Crohn's disease diagnosed in the Sixth Affiliated Hospital of Sun Yat-Sen University from January 2020 to June 2022. 2.The patients were treated with Ustekinumab and followed up regularly for 20 weeks. 3. Complete pre-treatment cross-sectional imaging data (CTE/MRE and US)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endoscopic remission rate at 12 months	endoscopic remission rate at 12 months	12 months after first intervention administration
normalization rate of serum biomarker at 12 months	normalization rate of serum biomarker at 12 months	12 months after first intervention administration
clinical remission rate at 12 months	clinical remission rate at 12 months	12 months after first intervention administration
clinical response rate at 12 months	clinical response rate at 12 months	12 months after first intervention administration
endoscopic response rate at 12 months	endoscopic response rate at 12 months	12 months after first intervention administration
life quality changes at 12 months	life quality evaluated by CDAI (Crohn's Disease Activity Index) at 12 months	12 months after first intervention administration
endoscopic remission rate after induction therapy	endoscopic remission rate after induction therapy	16 or 20 weeks after first intervention administration
normalization rate of serum biomarker after induction therapy	normalization rate of serum biomarker after induction therapy	16 or 20 weeks after first intervention administration
clinical remission rate after induction therapy	clinical remission rate after induction therapy	16 or 20 weeks after first intervention administration
clinical response rate after induction therapy	clinical response rate after induction therapy	16 or 20 weeks after first intervention administration
endoscopic response rate after induction therapy	endoscopic response rate after induction therapy	16 or 20 weeks after first intervention administration
life quality changes after induction therapy	life quality evaluated by CDAI (Crohn's Disease Activity Index) after induction therapy	16 or 20 weeks after first intervention administration

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Crohn Disease; Biologics
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2022ZSLYEC-317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No