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EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: Focus on ANCA-associated vasculitis
  1. Bernhard Hellmich (hellmich{at}rheuma-zentrum.de)
  1. University Hospital of Schleswig-Holstein, Germany
    1. Oliver Flossmann (oflossmann{at}doctors.org.uk)
    1. Addenbrooke’s Hospital, United Kingdom
      1. Wolfgang L Gross (gross{at}rheuma-zentrum.de)
      1. University Hospital of Schleswig-Holstein, Germany
        1. Paul Bacon (p.a.bacon{at}bham.ac.uk)
        1. University of Birmingham, United Kingdom
          1. Jan Willem Cohen-Tervaert (jw.cohentervaert{at}immuno.unimaas.nl)
          1. University Hospital Maastricht, Netherlands
            1. Loic Guillevin (loic.guillevin{at}wanadoo.fr)
            1. University of Paris Descartes, France
              1. David Jayne (dj106{at}cam.ac.uk)
              1. Addenbrooke’s Hospital, United Kingdom
                1. Alfred Mahr (amahr{at}bu.edu)
                1. Boston University School of Medicine, United States
                  1. Peter A Merkel (pmerkel{at}bu.edu)
                  1. Boston University School of Medicine, United States
                    1. Heiner Raspe (heiner.raspe{at}sozmed.uni-luebeck.de)
                    1. University Hospital of Schleswig-Holstein, Germany
                      1. David GI Scott (david.scott{at}nnuh.nhs.uk)
                      1. University of East Anglia, United Kingdom
                        1. James Witter (witterj{at}cder.fda.gov)
                        1. U.S. Food and Drug Administration, United States
                          1. Hasan Yazici (hyazici{at}attglobal.net)
                          1. University of Istanbul, Turkey
                            1. Raashid A Luqmani (raashid.luqmani{at}noc.anglox.nhs.uk)
                            1. University of Oxford, United Kingdom

                              Abstract

                              Objectives:To develop EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis.

                              Methods:An expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing 5 European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence-based and expert opinion-based approach in accordance with the standardised EULAR operating procedures, the group identified 9 topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis.

                              Results:Based on the results of the literature research the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti-neutrophil cytoplasm antibody associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to address vasculitis-specific issues rather than general issues of trial methodology. The recommendations address the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant endpoints, and biomarkers. On the basis of expert opinion, a number of aspects of trial methodology were deemed important for future research.

                              Conclusions: On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well designed research in non AAV systemic vasculitides.

                              • antineutrophil cytoplasm antibody
                              • clinical trial
                              • cytotoxic
                              • vasculitis

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