Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomised controlled trial.
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Multi-centre, international, open label, factorial design, randomized control trial in severe ANCA-associated vasculitis (AAV). Five hundred participants will be randomized, 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 500 patients will be randomized, 1:1, to receive reduced-dose GC taper or standard-dose GC taper.
We are very pleased to announce that the first patient was randomised into PEXIVAS on Tuesday 8th June 2010 from Addenbrooke's Hospital, Cambridge, UK.
Trial Chief Investigator: David Jayne (UK and Europe), Peter A. Merkel (USA) and Michael Walsh (Canada)
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Funding: National Institutes of Health Research (UK): Number, HTA 08/56/04, Food and Drug Administration/National Institutes of Health (USA): FDA R01 FD003516 and the National Institutes of Health (USA) - National Institute of Arthritis and Musculoskeletal and Skin Diseases: U54 AR0573319, National Health and Medical Research Council (Australia): 626939 and Canadian Institutes of Health Research (Canada): 211079.
EudraCT Number: 2009-013220-24
REC Outer West London: 09/H0709/56
MHRA: CTA Ref. 21857/0006/001-0001