Investigating immunogenicity to biopharmaceutics version 2

  • Research type

    Research Study

  • Full title

    Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK

  • IRAS ID

    126303

  • Contact name

    Claudia Mauri

  • Contact email

    c.mauri@ucl.ac.uk

  • Sponsor organisation

    University College London Hospital NHS Trust

  • 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 starting on BP drugs, collecting clinical data and testing 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

    London - City & East Research Ethics Committee

  • REC reference

    14/LO/0506

  • Date of REC Opinion

    16 Jun 2014

  • REC opinion

    Further Information Favourable Opinion