A multicenter double-blind controlled study of lobenzarit, a novel immunomodulator, in rheumatoid arthritis

A multicenter double-blind study was carried out in patients with rheumatoid arthritis (RA) by comparing treatment with a novel immunomodulator, lobenzarit, disodium 4-chloro-2, 2'-iminodibenzoate, with an inert placebo. Both groups of patients received 75 mg/day of indomethacin as a basal regimen during the study period of 16 weeks. Group 1 (115 patients) received 240 mg/day lobenzarit, 80 mg TID, and Group 2 (115 patients) received placebo TID orally. A statistically significant improvement was noted in the number of swollen joints and in the Lansbury index at Weeks 12 and 16 in Group 1 as compared to Group 2. Overall clinical effectiveness was significantly higher in Group 1 (63%) than in Group 2 (43%). Incidence of side effects was 38% in Group 1 and 22% in Group 2. The most frequent side effect in both groups was gastrointestinal upset. Our data confirm that lobenzarit is a useful agent in the treatment of patients with RA.