Clinical trial NCT05642247: Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
Official title: Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Biologics
Keywords: Crohn Disease
Biologics
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: January 2020 to June 2022 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University, who were treated with Ustekinumab.

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.


Eligibility criteria: 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

Primary outcomes:
measure: endoscopic remission rate at 12 months
timeFrame: 12 months after first intervention administration
measure: normalization rate of serum biomarker at 12 months
timeFrame: 12 months after first intervention administration
measure: clinical remission rate at 12 months
timeFrame: 12 months after first intervention administration
measure: clinical response rate at 12 months
timeFrame: 12 months after first intervention administration
measure: endoscopic response rate at 12 months
timeFrame: 12 months after first intervention administration
measure: life quality changes at 12 months
timeFrame: 12 months after first intervention administration
measure: endoscopic remission rate after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
measure: normalization rate of serum biomarker after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
measure: clinical remission rate after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
measure: clinical response rate after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
measure: endoscopic response rate after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
measure: life quality changes after induction therapy
timeFrame: 16 or 20 weeks after first intervention administration
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: