Biologics in refractory vasculitis (BIOVAS)
Research type
Research Study
Full title
Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children
IRAS ID
269769
Contact name
David Jayne
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2019-003964-30
ISRCTN Number
ISRCTN16502655
Duration of Study in the UK
5 years, 5 months, 28 days
Research summary
Vasculitis occurs when the body’s immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens (refractory vasculitis). These particular patients are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects.
Biologics are newer expensive drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Although biologics have been used for several years to treat vasculitis, for many of the rarer types of non- anti-neutrophil cytoplasmic antibodies (ANCA) associated vasculitis we do not have good data to guide the optimal choice of biologic.
The purpose of this study is to establish whether these biologic drugs are effective and represent value for money for patients with refractory NAAV.
NAAV (non-ANCA associated vasculitis) is a group of rare diseases that behave similarly in both adults and children and are treated in a similar fashion. In order to address the limited available data on the use of biologics, and to apply the results of the trial across the NAAV diseases studied, children will be included. The trial protocol, risks and benefits will be thoroughly discussed with parents/guardians who provide consent for a child's participation in the trial.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/1002
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion