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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43725

Enrollment

Registered

2015-05-13

Start date

2015-04-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

crohn's disease Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Refusal to participate

Design outcomes

Primary

Measure	Time frame
correlation between the infliximab/ inflectraTL determined by the lateral flow assay TL and the traditional ELISA	—

Secondary

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

Countries

Netherlands

Outcome results