ALEVIATE: long term follow up study

  • Research type

    Research Study

  • Full title

    ALEmtuzumab for relapsing and refractory primary systemic VasculitIs – a Trial of Efficacy and safety (ALEVIATE): long term follow up study

  • IRAS ID

    260928

  • Contact name

    David Jayne

  • Contact email

    dj106@cam.ac.uk

  • Sponsor organisation

    Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

  • Duration of Study in the UK

    4 years, 0 months, 1 days

  • Research summary

    Alemtuzumab is an effective drug for inducing remission (disease control) in primary systemic vasculitis (a rare group of conditions which cause inflammation of blood vessels) which has recurred after initial control (relapsed) or is particularly difficult to treat (refractory).
    However, two longer term issues still need to be addressed :
    1. This beneficial effect is not sustained long term and disease relapses frequently occur
    2. At least 1 in 5 individuals go on to develop new onset autoimmunity (most commonly affecting the thyroid gland) after alemtuzumab
    Alemtuzumab acts on lymphocytes (white blood cells) and by understanding how these cells recover in individual patients, we aim to identify patterns which may predict future clinical course.

  • REC name

    Wales REC 7

  • REC reference

    19/WA/0254

  • Date of REC Opinion

    2 Sep 2019

  • REC opinion

    Favourable Opinion