Evaluating a rapid on-site test for the monitoring of infliximab trough levels- a pilot study

Completed

• Conditions: 10017969; crohn's disease; Inflammatory bowel disease

• Registration Number: NL-OMON43725
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• Diagnosis of ulcerative colitis, Crohn*s colitis or IBD unclassified
• Current use of infliximab
• Age > 18 years
• Signed informed consent

Exclusion Criteria

Refusal to participate

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> correlation between the infliximab/ inflectraTL determined by the lateral flow<br /><br>assay TL and the traditional ELISA</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The accuracy of quantitative measurements in the IFX concentration range of<br /><br>2-12 mg/mL, to determine how results potentially can be used to immediately<br /><br>change infusion schemes<br /><br>The duration of the test, measured from taking the blood samples to receiving<br /><br>the result.</p><br>