As part of the proposal for drug development using the SMARD/DC-ART de
finitions, ''decreased inflammatory synovitis'' needs to be defined. W
e review the literature with respect to each of the indirect, clinical
measures of decreased inflammatory synovitis and recommend a prelimin
ary, testable definition based on a per patient response. It includes
minimum disease activity criteria for patients entering studies and im
provement in at least 5 of the following 6 criteria: greater than 20%
improvement in joint swelling count; greater than 20% improvement in j
oint tenderness count; greater than 20%; improvement in erythrocyte se
dimentation rate; greater than 30% improvement in physician/assessor g
lobal assessment; greater than 30% improvement in pain. While this def
inition is sensible within the confines of our knowledge to date, usin
g these critera prospectively in several clinical trials will allow be
tter definition of the appropriate pooled index to define decreased in
flammatory synovitis.