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

NCT06849739 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

biologic therapy(eg:IFX,ADA,UST,VDZ)

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849739 on ClinicalTrials.gov