Double-blind, placebo-controlled study of OM-8980 in rheumatoid arthritis.

A total of 95 patients suffering from active rheumatoid arthritis were included in this double-blind, placebo-controlled study of the immunomodulator OM-8980. Treatment was one capsule daily of OM-8980 or placebo for 6 months. A significant improvement was observed in the OM-8980 group in comparison with the placebo group as regards the Ritchie index (P = 0.002), grip strength (P = 0.02) and pain (P = 0.03). The number of swollen joints, duration of morning stiffness and erythrocyte sedimentation rate decreased more markedly under OM-8980 than under the placebo, without reaching the level of statistical significance. A significant difference in favour of OM-8980 was observed in the intake of non-steroidal anti-inflammatory drugs and oral corticosteroids. Clinical tolerance was on the whole good (10 cases with side effects out of 49 in the OM-8980 group and 7 out of 46 in the placebo group, ns), with the majority of the side effects concerning the gastrointestinal system. The global assessment of the therapeutic efficacy both by the physician and the patient showed a highly significant superiority of OM-8980 over the placebo (P = 0.001).