Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomised controlled trial.
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What is PEXIVAS?
PEXIVAS is a multi-centre, international, open label, factorial design, randomised control trial in severe ANCA-associated vasculitis (AAV). Seven hundred participants will be randomised, 1:1, to receive adjunctive plasma exchange (PLEX) in addition to standard immunosuppressive therapy and glucocorticoids (GC) or standard immunosuppressive therapy and GC without PLEX. The same 700 patients will be randomised, 1:1, to receive reduced-dose GC taper or standard-dose GC taper.
The first patient was randomised into PEXIVAS on Tuesday 8th June 2010 from Addenbrooke's Hospital, Cambridge, UK. Since then the trial has grown to encompass over 100 hundred centres around the world and recruited over 500 patients. The trial is scheduled to recruit all seven hundred patients by December 2016 and is scheduled to end in December 2017
UK and Europe: David Jayne
USA: Peter A. Merkel
Canada: Michael Walsh
Sponsor and Regulatory Information
Sponsor: Cambridge University Hospitals NHS Foundation Trust
EudraCT Number: 2009-013220-24
REC Outer West London: 09/H0709/56
MHRA: CTA Ref. 21857/0006/001-0001
National Institutes of Health Research (UK): Number, HTA 08/56/04
Food and Drug Administration/National Institutes of Health (USA): FDA R01 FD003516
National Institutes of Health (USA) - National Institute of Arthritis and Musculoskeletal and Skin Diseases: U54 AR0573319
National Health and Medical Research Council (Australia): 626939
Canadian Institutes of Health Research (Canada): 211079.