Outcome Measures for Gout Clinical Trials: a Summary of Progress

Abstract

Gout is the most common form of inflammatory arthritis. With the development of new agents for the treatment of gout in the last decade, the lack of validated outcome measures for clinical trials in gout has become apparent. Gout has been a topic of discussion at Outcomes in Rheumatology Clinical Trials (OMERACT) meetings since 2002. This work has included identification of core domains for outcome measures for both acute and chronic gout studies. More recently, OMERACT have endorsed a number of these domains and measurement instruments for these domains. The domains appear to be largely relevant to patients with gout but additional issues have been identified, including the absence of an endorsed disease-specific measure of health-related quality of life. Concurrently, a preliminary definition of flare has been developed and leading from this, early versions of composite measures of disease activity and response criteria. With the ability for excellent serum urate control, remission should be possible and preliminary remission criteria have been proposed. Flare definition, response criteria and remission criteria require further validation. The role of serum urate as a biomarker for chronic gout studies is promising, but further work is required to show that serum urate is a biomarker of relevant clinical outcomes.