Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- life quality changes at 12 months
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Outcomes
Primary Outcomes
life quality changes at 12 months
Time Frame: 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
Time Frame: 16 or 20 weeks after first intervention administration
endoscopic remission rate after induction therapy
normalization rate of serum biomarker after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
normalization rate of serum biomarker after induction therapy
normalization rate of serum biomarker at 12 months
Time Frame: 12 months after first intervention administration
normalization rate of serum biomarker at 12 months
endoscopic remission rate at 12 months
Time Frame: 12 months after first intervention administration
endoscopic remission rate at 12 months
clinical remission rate at 12 months
Time Frame: 12 months after first intervention administration
clinical remission rate at 12 months
clinical response rate at 12 months
Time Frame: 12 months after first intervention administration
clinical response rate at 12 months
endoscopic response rate at 12 months
Time Frame: 12 months after first intervention administration
endoscopic response rate at 12 months
clinical remission rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
clinical remission rate after induction therapy
clinical response rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
clinical response rate after induction therapy
endoscopic response rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
endoscopic response rate after induction therapy
life quality changes after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
life quality evaluated by CDAI (Crohn's Disease Activity Index) after induction therapy
Secondary Outcomes
No secondary outcomes reported