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Therapeutic Effect of New Biologics in Crohn's Disease

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ClinicalTrials.gov Identifier: NCT04923100
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : December 5, 2023
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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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
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Treatment Side Effects

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Therapeutic Effect of New Biologics in Crohn's Disease
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : March 29, 2024
Estimated Study Completion Date : March 29, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. endoscopic remission [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
intestinal mucosa biopsy

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923100


Contacts
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Contact: Jiayin Yao 13826462890 yjyin3@mail.sysu.edu.cn

Locations
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China, Guangdong
the Sixth Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 501655
Contact: Jiayin Yao    13826462890    yjyin3@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04923100    
Other Study ID Numbers: 2021ZSLYEC-066
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: December 5, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases