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

Completed

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Biologics

• Registration Number: NCT05642247
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-08
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China