OM-8980 in rheumatoid arthritis: a 6-month double blind placebo controlled multicenter study.

A new immunomodulating drug, OM-8980, was compared to placebo in a 6-month double blind multicenter trial including 107 patients with active rheumatoid arthritis. Ritchie index, number of swollen joints and the pain scale improved significantly more with OM-8980 than with placebo. Grip strength, duration of morning stiffness and erythrocyte sedimentation rate improved more markedly with OM-8980 than with placebo, but the difference did not reach statistical significance. The use of analgesic and antiinflammatory drugs diminished significantly more with OM-8980 than with placebo. Clinical tolerance was good with 7 side effects reported in 3 of the 52 patients included in the OM-8980 group and 11 in 8 patients of the 55 in the placebo group (mostly gastrointestinal troubles and skin reactions). In the overall evaluation by both patients and physicians OM-8980 was significantly superior to placebo.