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

NCT06849739 | Not Yet Recruiting

• 1 other identifier: NFEC-2024-563
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• plasma concentration

  plasma concentration refers to the total concentration of a biologic drug（such as infliximab, adalimumab, vedolizumab, and ustekinumab） in the plasma after absorption.

  During hospitalization for biologic injections，an average of 1 week

Study Arms (4)

infliximab group

IBD patients using infliximab

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

adalimumab group

IBD patients using adalimumab

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

vedolizumab group

IBD patients using vedolizumab

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

ustekinumab group

IBD patients using ustekinumab

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

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

adalimumab group; infliximab group; ustekinumab group; vedolizumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the treating physician's judgment, IBD patients require biologic therapy with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) .

You may qualify if:

• Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) .

You may not qualify if:

• Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: February 27, 2025
• Study Start: March 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)