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

April 23, 2026 updated by: Sixth Affiliated Hospital, Sun Yat-sen University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501655
        • The Sixth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
endoscopic remission rate at 12 months
Time Frame: 12 months after first intervention administration
endoscopic remission rate at 12 months
12 months after first intervention administration
normalization rate of serum biomarker at 12 months
Time Frame: 12 months after first intervention administration
normalization rate of serum biomarker at 12 months
12 months after first intervention administration
clinical remission rate at 12 months
Time Frame: 12 months after first intervention administration
clinical remission rate at 12 months
12 months after first intervention administration
clinical response rate at 12 months
Time Frame: 12 months after first intervention administration
clinical response rate at 12 months
12 months after first intervention administration
endoscopic response rate at 12 months
Time Frame: 12 months after first intervention administration
endoscopic response rate at 12 months
12 months after first intervention administration
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
12 months after first intervention administration
endoscopic remission rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
endoscopic remission rate after induction therapy
16 or 20 weeks after first intervention administration
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
16 or 20 weeks after first intervention administration
clinical remission rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
clinical remission rate after induction therapy
16 or 20 weeks after first intervention administration
clinical response rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
clinical response rate after induction therapy
16 or 20 weeks after first intervention administration
endoscopic response rate after induction therapy
Time Frame: 16 or 20 weeks after first intervention administration
endoscopic response rate after induction therapy
16 or 20 weeks after first intervention administration
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
16 or 20 weeks after first intervention administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022ZSLYEC-317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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