NCT05642247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

August 30, 2022

Last Update Submit

April 23, 2026

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseBiologics

Keywords

Crohn DiseaseBiologics

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (1)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • The diagnosis is not clear
  • Under the age of 18
  • Lack of endoscopic and pathological data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

December 8, 2022

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

CN(1)