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.
Brackertz
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St. Vincenz- und Elisabeth-Hospital, Mainz, Federal Republic of Germany.
Vischer
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TL
D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010147:Pain Measurement; D011897:Random Allocation