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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05642247

Enrollment

150

Registered

2022-12-08

Start date

2022-07-01

Completion date

2023-01-31

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biologics, Crohn Disease, Inflammatory Bowel Diseases

Keywords

Crohn Disease, Biologics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
endoscopic remission rate at 12 months	12 months after first intervention administration	endoscopic remission rate at 12 months
normalization rate of serum biomarker at 12 months	12 months after first intervention administration	normalization rate of serum biomarker 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
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
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

Countries

China

Outcome results