This double-blind randomized controlled trial compares the efficacy of droxicam (20mg/day) and that of indomethacin (100mg/day) administered to 20 patients (7 men, 13 women; aged 54.7 +/- 13.2 years) with active classical or definite rheumatoid arthritis during 9 weeks, after a 7-day single-blind run-in paracetamol (1,500mg/day) period. Evaluations were carried out at weeks 0 (washout), 1,2,4,6 and 9. After 9 weeks of treatment, both drugs showed a statistically significant improvement of joint pain intensity, articular index (number of swollen or painful joints and degree of involvement), duration of morning stiffness, functional capacity, and level of fatigue. Inter-treatment differences at all study intervals were not observed. Grip strength improved only in indomethacin-treated patients. Withdrawals due to lack of therapeutic efficacy did not occur. Side effects occurred in four patients from each group. One patient in the indomethacin group withdrew at the week 1 due to epigastric pain and heartburn. In conclusion, droxicam (20mg/day) seems to be as effective as indomethacin (100mg/day) in the alleviation of symptoms in patients with rheumatoid arthritis.