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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Biologics

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CD patients who received Ustekinumab treatment<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Biologics