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Etodolac was compared with aspirin and placebo for efficacy and safety, and a minimum effective dose was established in 264 patients with adult-onset, active rheumatoid arthritis. In this six-week, 14-center, double-blind, parallel-group investigation, preceded by a washout period of up to two weeks, patients received daily doses of etodolac at 50, 100, or 200 mg/d; aspirin at 3,900 mg/d; or placebo. Both etodolac at the highest dose and aspirin produced statistically significant improvement from baseline in all disease activity assessments measured at four- and six-week end points and were superior to placebo in the majority of assessments. A greater number of patient complaints occurred with aspirin, especially in regard to gastrointestinal-related and otologic side effects. A significant therapeutic dose response was evident among the etodolac groups without an increase in side effects. Although the 100-mg/d dose was effective in many of the efficacy parameters measured, the 200-mg/d dose, which is comparably efficacious to aspirin 3.9 g/d, was suggested as the minimum effective dose for the relief of the signs and symptoms of active rheumatoid arthritis.