Assessment in Ankylosing Spondylitis International Working Group/Spondylitis Association of America recommendations for conducting clinical trials in ankylosing spondylitis

Within the field of research in spondylarthritis, there has been an increasing interest in proposing new sets of recommendations, integrating current knowledge, for conducting clinical research in ankylosing spondylitis (AS). In May 2001, the US Food and Drug Administration (FDA) requested assistance from all interested outside parties in the development of a document for pharmaceutical and medical-device industries that would provide guidance on the approval of drugs, biologic products, and devices for the treatment of AS. Both the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group and the Spondylitis Association of America (SAA; a patient advocacy organization) expressed interest in the development of the document and formed a steering committee. Members of this coalition held a consensus meeting to provide written recommendations that could serve as a basis for the FDA guidance document for AS. This document may serve a broader goal of providing recommendations on trial design and outcome assessment in AS for the rheumatology community. Prior work of the ASAS International Working Group provided a basis for development of the document. The ASAS International Working Group and the SAA formed a steering committee that identified 6 topics on which to focus: scope of the disease, definition of claims, assessment of signs and symptoms, assessment of function, assessment of structural damage, and trial design. These topics reflected the structure of FDA guidance documents for rheumatoid arthritis (RA) and osteoarthritis (OA). Planning committees corresponding to each of the topics were identified by the steering committee and prepared background information based on literature review and consensus work already done by the ASAS International Working Group as well as the personal expertise of the group members. Members of these committees are listed in Appendix A. Based on this information, each group made a proposal for further discussion of its topic, at a public meeting that was held on October 30 and 31, 2002, in Bethesda, Maryland. This meeting was convened to permit interested parties the opportunity to review and comment on the draft criteria developed by the planning committees and was attended by 90 representatives, as follows: 45 from the ASAS International Working Group, 23 from the SAA, 15 from pharmaceutical companies, and 11 from government (the FDA and the National Institutes of Health). After wide advertisement in the rheumatology community, the interested parties were self-selected. No formal voting occurred during the public meeting, but there was open communication regarding various aspects of the topics. All discussions were taped, and the tapes were transcribed. Based on these transcriptions, the chair of the planning committee for each topic produced a summary with conclusions and recommendations, and this was again discussed by the steering Desiree van der Heijde, MD, PhD: University Hospital Maastricht, and the Care and Public Health Research Institute of the University Maastricht, Maastricht, The Netherlands; Maxime Dougados, MD, PhD: Universite Rene Descartes, Hopital Cochin, Paris, France; John Davis, MD, MPH: University of California, San Francisco; Michael H. Weisman, MD, David S. Hallegua, MD: CedarsSinai Medical Center, and University of California, Los Angeles School of Medicine; Walter Maksymowych, FRCP: University of Alberta, Alberta, Edmonton, Canada; Jurgen Braun, MD: Rheumazentrum Ruhrgebiet, Herne, Germany, and Free University, Berlin, Germany; Jane Bruckel, RN, BSN: Spondylitis Association of America, Sherman Oaks, California. Address correspondence and reprint requests to Desiree van der Heijde, MD, PhD, University Hospital Maastricht, Department of Internal Medicine/Rheumatology, PO Box 5800, 6202 AZ Maastricht, The Netherlands. E-mail: dhe@sint.azm.nl. Submitted for publication January 6, 2004; accepted in revised form October 26, 2004.

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