As part of the clinical investigation of a new biologic agent in the treatment of rheumatoid arthritis (RA) various outcome measures were utilized to evaluate clinical activity in two multicenter open label protocols. These measures included the single criteria of joint tenderness and swelling counts and scores and composite criteria based on the Paulus analysis of four placebo-controlled CSSRD studies of second line agents in RA. Findings suggest a difference in the pattern of response between early and long-standing RA. Changes in both the swollen and tender joint counts should be utilized, especially in a population with sustained disease.