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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642247
• Other study ID #: 2022ZSLYEC-317
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biologics
• Crohn Disease
• Inflammation
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopic remission rate at 12 months	endoscopic remission rate at 12 months	12 months after first intervention administration
Primary	normalization rate of serum biomarker at 12 months	normalization rate of serum biomarker at 12 months	12 months after first intervention administration
Primary	clinical remission rate at 12 months	clinical remission rate at 12 months	12 months after first intervention administration
Primary	clinical response rate at 12 months	clinical response rate at 12 months	12 months after first intervention administration
Primary	endoscopic response rate at 12 months	endoscopic response rate at 12 months	12 months after first intervention administration
Primary	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
Primary	endoscopic remission rate after induction therapy	endoscopic remission rate after induction therapy	16 or 20 weeks after first intervention administration
Primary	normalization rate of serum biomarker after induction therapy	normalization rate of serum biomarker after induction therapy	16 or 20 weeks after first intervention administration
Primary	clinical remission rate after induction therapy	clinical remission rate after induction therapy	16 or 20 weeks after first intervention administration
Primary	clinical response rate after induction therapy	clinical response rate after induction therapy	16 or 20 weeks after first intervention administration
Primary	endoscopic response rate after induction therapy	endoscopic response rate after induction therapy	16 or 20 weeks after first intervention administration
Primary	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