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Guidance Document Published - SAA Continues to be a Leader in the Quest to Cure AS and Related Diseases

3/23/2005

An important endeavor undertaken by the SAA, the Assessment in Ankylosing Spondylitis (ASAS) International Working Group and others over the last few years was to assist the FDA in creating a Guidance Document for Industry for ankylosing spondylitis. This kind of document provides standardized methods to assess the results of therapy or device being studied in regards to ankylosing spondylitis. This work culminated in the finalized document being published in the medical journal, Arthritis & Rheumatism, in February of 2005.

The article, "Assessment in Ankylosing Spondylitis International Working Group/Spondylitis Association of America recommendations for conducting clinical trials in ankylosing spondylitis", will help standardized methods in studies of AS and provide important, expert recommendations that will be critical in guiding future research.

History of the Guidance Document
In May of 2001, the US Food and Drug Administration (FDA) requested assistance 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 SAA and ASAS heeded the call and formed a steering committee.

This committee oversaw a meeting in October of 2001 held in Bethesda, Maryland that was comprised of highly respected researchers from around the world, pharmaceutical giants and representatives from the FDA. David Hallegua, MD who was and still is the President of SAA's Board of Directors, and Desiree van der Heijde, from the Netherlands, co-chaired the steering committee.

Through debate, discussion and open communication within the coalition that was formed, recommendations and conclusions were eventually agreed upon. The result is a document that targets all of those who are interested in AS: Clinicians, clinical and basic researchers, regulatory bodies, patients, support and advocacy groups as well as the public at large.

Want to read the document? The document was published in the journal, Arthritis & Rheumatism, Volume 52, Issue 2, on pages 386-394, in February 2005. It is currently available for purchase online at: http://www3.interscience.wiley.com/cgi-bin/jissue/109891844


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