Spring in Cambridge. View from Clare College Gardens. Spring edition. Content: VOLUME 1, ISSUE 4 PEXIVAS. PEXIVAS Investigators Meeting Vancouver 2011

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1 VOLUME 1, ISSUE PEXIVAS Spring edition Content: PEXIVAS Investigators Meeting Vancouver 011 Recruitment and active centres Meetings SAE s and reporting process Spring in Cambridge. View from Clare College Gardens.

2 PEXIVAS Investigators Meeting in Vancouver April 7, 011 Thank you to all of you who attended the PEXIVAS Investigators Meeting held in Vancouver during the WCN. At the meeting Dr. Michael Walsh, our host, gave a brief update on where the Canadian centers are with their participation in PEXIVAS, as well as an overview of the protocol. We also reviewed the progress of centers globally. Thank you to Dr. Chen Au Peh for the Australian/New Zealand update. The participants reviewed BVAS/WG cases during the interactive session led by Dr. Alina Cassian, Meeting at the Pan Pacific, Vancouver Biljana Brezina led a session on current SAE s and also reviewed the importance of timely and correct reporting of SAE s. And finally a big thank you to Katy Vela for helping us by bringing some necessary technical equipment. Well done Canada! View at the WCN congress center

3 Recruitment by centres Centres in the process of getting necessary approvals Azienda Ospedaliero-Universitaria di Parma, Parma, Italy Basildon and Thurrock University Hospitals NHS Foundation Trust, UK Brighton and Sussex University Hospitals NHS Trust, Brighton, UK Fundacio Puigvert, Barcelona, Spain General Faculty Hospital, Prague, Czech Republic Heart of England Foundation NHS Trust, Birmingham, UK Hospital San Martin, La Plata, Argentina Lothian University Hospitals NHS Trust, UK University Hospital Brugmann, Brussels, Belgium Medizinische Hochschule Hannover, Germany Marmara University, School of Medicine Hospital, Istanbul, Turkey Newcastle Hospitals NHS Foundation Trust, UK Royal Berkshire NHS Foundation Trust, UK University Hospital Jena, Germany Centres in Australia & New Zealand Centres in Canada Centres in USA Centres in Greece, Japan, Mexico, Poland

4 MEETINGS PEXIVAS was discussed at the ANCA Workshop at Chapel Hill, NC, USA on May Topics discussed include: - Participating centres and SAE reporting. - Sample handling and biomarkers studies. - Protocol highlights. - BVAS/WG training etc. Pellentesque: Your PEXIVAS PI s hard at WORK NEXT MEETINGS PEXIVAS Investigators Meeting at the ERA-EDTA, Prague, Czech Republic June, 011, , Corinthia Hotel, Kongresova 1, Prague, 10 69, Czech Republic 8 th International Society for Apheresis Congress September 1-17, 011, University Hospital, Vienna, Austria Consectetuer: Joint PEXIVAS/GloMY Investigators Meeting October, 011, Birmingham, UK 10 th Congress-BANTAO of the Balkan Cites Association of Nephrology, Dialysis, Transplantation and Artificial Organs October 1, 011, Sani Beach Hotel, Chalkidiki, Greece ACR/ARHP 011 Annual Scientific Meeting November -9, 011, Chicago, IL, USA

5 SAE (SERIOUS ADVERSE EVENT ) REPORTING SAEs MUST be reported, as soon as possible (and within 7 days) of occurrence. SUSARs (suspected unexpected) due to glucocorticoid (-trial IMP) or plasma exchange, report within hours. FAX or scan/ SAE form to or trial co-ordinator Biljana Brezina (bjovanovska@nhs.net). US centers: please also report SAEs to the Vasculitis Research Consortium Office in Boston: Peter Merkel (pmerkel@bu.edu) and Carol McAlear (caking@bu.edu); Tel No: , Fax: Australian / New Zealand centers: please also report SAEs to the Australasian Kidney Trials Network: Alicia Morrish (a.morrish@uq.edu.au) and Donna Reidlinger (d.reidlinger@uq.edu.au); Tel No: ). Canadian centers: please also report SAEs to the Dr. Michael Walsh (lastwalsh197@gmail.com) Fax No: ! 1 SAE s reported by the end of May 011! No SUSAR s reported so far.! Interesting point: From those 1 SAE s, 1 SAE s are from 9 recruited patients from Cambridge. Only SAEs reported from the rest of the centres ( patients in total). Underreporting maybe? The first DMC/DSMB is going to take place next month, July 011. More information about that in the next newsletter.