Therapeutic Effect of New Biologics in Crohn's Disease

December 3, 2023 updated by: Sixth Affiliated Hospital, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 80 years (Child, Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
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
short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
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
short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Estimated)

March 29, 2024

Study Completion (Estimated)

March 29, 2025

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021ZSLYEC-066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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