ABIRISK cross sectional study protocol- MS patients
Research type
Research Study
Full title
Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK: cross sectional study for patients with MS
IRAS ID
173913
Contact name
Elizabeth Jury
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
8, Partner number; Z6364106/2015/03/170, Data protection registration; 15/0237, R and D Number
Duration of Study in the UK
1 years, 10 months, 28 days
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 West - Central Bristol Research Ethics Committee
REC reference
15/SW/0109
Date of REC Opinion
20 Apr 2015
REC opinion
Favourable Opinion