Inflammatory Bowel DiseasesNCT05642247
Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Biologics
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- The diagnosis is not clear
- Under the age of 18
- Lack of endoscopic and pathological data
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 501655
About this study
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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Biologics
- Keywords
- Crohn Disease, Biologics
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
endoscopic remission rate at 12 months
endoscopic remission rate at 12 months
Measured: 12 months after first intervention administration
normalization rate of serum biomarker at 12 months
normalization rate of serum biomarker at 12 months
Measured: 12 months after first intervention administration
clinical remission rate at 12 months
clinical remission rate at 12 months
Measured: 12 months after first intervention administration
clinical response rate at 12 months
clinical response rate at 12 months
Measured: 12 months after first intervention administration
endoscopic response rate at 12 months
endoscopic response rate at 12 months
Measured: 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
Measured: 12 months after first intervention administration
endoscopic remission rate after induction therapy
endoscopic remission rate after induction therapy
Measured: 16 or 20 weeks after first intervention administration
normalization rate of serum biomarker after induction therapy
normalization rate of serum biomarker after induction therapy
Measured: 16 or 20 weeks after first intervention administration
clinical remission rate after induction therapy
clinical remission rate after induction therapy
Measured: 16 or 20 weeks after first intervention administration
clinical response rate after induction therapy
clinical response rate after induction therapy
Measured: 16 or 20 weeks after first intervention administration
endoscopic response rate after induction therapy
endoscopic response rate after induction therapy
Measured: 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
Measured: 16 or 20 weeks after first intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642247
- Sponsor's protocol ID
- 2022ZSLYEC-317
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
- ClinicalTrials.gov ID
- NCT05642247
- Acronym / sponsor ID
- 2022ZSLYEC-317
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Biologics
- Keywords
- Crohn Disease, Biologics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- The diagnosis is not clear
- Under the age of 18
- Lack of endoscopic and pathological data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
endoscopic remission rate at 12 months
Time frame: 12 months after first intervention administration
endoscopic remission rate at 12 months
normalization rate of serum biomarker at 12 months
Time frame: 12 months after first intervention administration
normalization rate of serum biomarker 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic remission rate at 12 months (time frame: 12 months after first intervention administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.