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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05642247
Collaborator
(none)
150
Enrollment
1
Location
12
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
    Actual Study Start Date :
    Jul 29, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jul 29, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. endoscopic remission rate at 12 months [12 months after first intervention administration]

      endoscopic remission rate at 12 months

    2. normalization rate of serum biomarker at 12 months [12 months after first intervention administration]

      normalization rate of serum biomarker at 12 months

    3. clinical remission rate at 12 months [12 months after first intervention administration]

      clinical remission rate at 12 months

    4. clinical response rate at 12 months [12 months after first intervention administration]

      clinical response rate at 12 months

    5. endoscopic response rate at 12 months [12 months after first intervention administration]

      endoscopic response rate at 12 months

    6. 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

    7. endoscopic remission rate after induction therapy [16 or 20 weeks after first intervention administration]

      endoscopic remission rate after induction therapy

    8. normalization rate of serum biomarker after induction therapy [16 or 20 weeks after first intervention administration]

      normalization rate of serum biomarker after induction therapy

    9. clinical remission rate after induction therapy [16 or 20 weeks after first intervention administration]

      clinical remission rate after induction therapy

    10. clinical response rate after induction therapy [16 or 20 weeks after first intervention administration]

      clinical response rate after induction therapy

    11. endoscopic response rate after induction therapy [16 or 20 weeks after first intervention administration]

      endoscopic response rate after induction therapy

    12. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the Sixth Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong China 501655

    Sponsors and Collaborators

    • Sixth Affiliated Hospital, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sixth Affiliated Hospital, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05642247
    Other Study ID Numbers:
    • 2022ZSLYEC-317
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 8, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University
    Crohn Disease
    Biologics
    Additional relevant MeSH terms:
    Crohn Disease
    Inflammatory Bowel Diseases
    Inflammation

    Study Results

    No Results Posted as of Dec 8, 2022