Abstract | BACKGROUND: METHODS/DESIGN: PEXIVAS is a two-by-two factorial randomized trial evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. Five hundred patients are being randomized at centers across Europe, North America, Asia, and Australasia to receive plasma exchange or no plasma exchange, and to receive standard or reduced oral glucocorticoid dosing. All patients receive immunosuppression with either cyclophosphamide or rituximab. The primary outcome is the time to the composite of all-cause mortality and end-stage renal disease.PEXIVAS is funded by the National Institute of Health Research (UK), the Food and Drug Administration (USA), the National Institutes of Health (USA), the Canadian Institute of Health Research (Canada), the National Health and Medical Research Council (Australia), and Assistance Publique (France). Additional in-kind supplies for plasma exchange are provided by industry partners (TerumoBCT, Gambro Australia, and Fresenius Australia). DISCUSSION: This is the largest trial in AAV undertaken to date. PEXIVAS will inform the future standard of care for patients with severe AAV. The cooperation between investigators, funding agencies, and industry provides a model for conducting studies in rare diseases. TRIAL REGISTRATION: Current Controlled Trials: (ISRCTN07757494) and clinicaltrials.gov: (NCT00987389).
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Authors | Michael Walsh, Peter A Merkel, Chen Au Peh, Wladimir Szpirt, Loïc Guillevin, Charles D Pusey, Janak De Zoysa, Natalie Ives, William F Clark, Karen Quillen, Jeffrey L Winters, Keith Wheatley, David Jayne, PEXIVAS Investigators |
Journal | Trials
(Trials)
Vol. 14
Pg. 73
(Mar 14 2013)
ISSN: 1745-6215 [Electronic] England |
PMID | 23497590
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
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Topics |
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
(therapy)
- Clinical Protocols
- Glucocorticoids
(administration & dosage)
- Humans
- Plasma Exchange
- Sample Size
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