COMBIVAS biomarker validation study
Research type
Research Study
Full title
COMBIVAS biomarker validation study protocol
IRAS ID
355225
Contact name
Rachel Jones
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
This project will analyse samples collected in previous ethically approved COMBIVAS study conducted in patients with ANCA Vasculitis.
COMBIVAS was a randomised trial comparing rituximab with belimumab to rituximab with placebo in patients with PR3 ANCA Vasculitis. This means that patients were equally chosen at random to either receive the new active drug being tested as well as the current standard of care drug rituximab or just the standard of care drug. This trial included 35 patients. Analysis of results is currently ongoing. Further analyses on left over samples from this trial would be beneficial to help validate or provide further evidence to support the findings from the COMBIVAS trial.
The main research questions to be addressed using these samples are as follows:
1. Is there a reduction in the response from the blood B cells following treatment with rituximab + belimumab versus rituximab + placebo
2. Is there a reduction in certain specific B cells following treatment with rituximab + belimumab versus rituximab + placebo
3. Is there a reduction in markers of inflammation following treatment with rituximab + belimumab versus rituximab + placebo
Further questions may also arise in the future as the project progress and literature evolves, for which these samples will be a valuable source.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0159
Date of REC Opinion
20 May 2025
REC opinion
Favourable Opinion