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Therapeutic Effect of New Biologics in Crohn's Disease

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04923100
Collaborator
(none)
50
Enrollment
1
Location
9.6
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Therapeutic Effect of New Biologics in Crohn's Disease
    Anticipated Study Start Date :
    Jun 10, 2021
    Anticipated Primary Completion Date :
    Mar 29, 2022
    Anticipated Study Completion Date :
    Mar 29, 2022

    Outcome Measures

    Primary Outcome Measures

    1. endoscopic remission [short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)]

      Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2

    Secondary Outcome Measures

    1. clinical remission [short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)]

      Clinical remission was defined as Crohn's disease activity index (CDAI) below 150

    2. clinical response [short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)]

      endoscopic response referred to those with a reduction of SES-CD > 50% baseline

    3. endoscopic response [short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)]

      endoscopic response referred to those with a reduction of SES-CD > 50% baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.
    Exclusion Criteria:
    • loss of follow-up, incomplete clinical data, without confirmed diagnosis

    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:
    NCT04923100
    Other Study ID Numbers:
    • 2021ZSLYEC-066
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Jun 11, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Jun 11, 2021