Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT06849739
Status
Not Yet Recruiting

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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • biologic therapy(eg:IFX,ADA,UST,VDZ) — DRUG
    This study compares the detection of blood samples from IBD patients after biologic therapy(eg:IFX,ADA,UST,VDZ) using different methods

Study Details

In recent years, biologics (such as infliximab, adalimumab, vedolizumab, and ustekinumab) have shown great potential in the treatment of inflammatory bowel disease (IBD), transforming the traditional treatment model for IBD. Despite achieving good efficacy, some patients do not respond to biologics, which may be related to low drug concentrations in the blood. Guidelines recommend therapeutic drug monitoring (TDM) during the treatment of IBD. Currently, many commercial testing methods are available to detect the trough levels of biologics; however, data on the diagnostic accuracy and practicality of these methods remain limited. This study compares the detection of blood samples from IBD patients after administration using ELISA, PICA, and CLIA methods, aiming to provide more accurate guidance and evidence for TDM in Chinese IBD patients undergoing biologic therapy.

Key Dates

First listed
Feb 27, 2025
Start date
Mar 2, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: infliximab group
    IBD patients using infliximab
  • Arm: adalimumab group
    IBD patients using adalimumab
  • Arm: vedolizumab group
    IBD patients using vedolizumab
  • Arm: ustekinumab group
    IBD patients using ustekinumab

Primary Outcome Measure

plasma concentration [ Time Frame: During hospitalization for biologic injections，an average of 1 week ]

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