NCT06849739

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-02
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China