Investigating immunogenicity to biopharmaceutics cross sectional study
Research type
Research Study
Full title
Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK: cross sectional study
IRAS ID
142793
Contact name
Elizabeth Jury
Contact email
Sponsor organisation
University College London Hospital NHS Trust
Clinicaltrials.gov Identifier
8, Partner number; Z6364106/2014/07/64, Data protection registration; B1262FI0153313, Insurance reference number
Research summary
It is thought that one of the reasons that patients do not respond, or lose response, to treatment with biopharmaceutical drugs (BP) is the development of anti-drug antibodies (ADA).The ability to predict which patients will develop these antibodies and then prevent ADA from having a negative effect on drug function, are therefore major goals for the future of BP drug development. Our research aims to identify and characterize ADA, to facilitate their detection in clinical practice, and thus to optimize patient response to treatment.
We will be recruiting patients who are already treated with BP drugs, from patients treated with conventional therapies and from healthy volunteers. We will collect clinical data and test for ADA, as well as other immune cell functions. We will look for correlations to allow us to optimize the predicition of drug response, and tailor individual patient treatment plans accordingly.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1200
Date of REC Opinion
18 Aug 2014
REC opinion
Favourable Opinion