Understanding ELISA anti-TNF monitoring assays
Research type
Research Study
Full title
How does the presence of anti-TNF drug affect the measurement of anti-drug antibodies, and vice-versa?
IRAS ID
206773
Contact name
Mandy Perry
Contact email
Sponsor organisation
Royal Devon & Exeter NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Infliximab and Adalimumab are very effective drug treatments of a serious lifelong disease affecting the gut called Crohn’s disease. Some sufferers of Crohn’s disease do not respond well to these drugs, either when it is first administered or later in the course of their treatment.
The patients that stop responding to the drugs develop proteins in their blood (called antibodies) which prevent the drug from working. We cannot predict which patients will make antibodies but we can look for the appearance of these proteins in patients routine blood samples.
Measuring the drug level (infliximab or adalimumab) and checking for the appearance of the antibodies in patients’ blood help us predict which patients will stop responding to their treatment. However, measuring the concentration of drug in blood from patients who have developed antibodies presents a technical challenge as the antibodies can interfere with the laboratory measurements.
This project is designed to establish the best way to measure both the drug level and the antibodies that stops the drugs working in patients with Crohn’s disease. By establishing this we can ensure we are providing robust test results to allow clinicians to make the right treatment decision for patients with Crohn’s disease.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0291
Date of REC Opinion
6 Jul 2016
REC opinion
Favourable Opinion