Follow-up with OM-8980 after a double-blind study of OM-8980 and auranofin in rheumatoid arthritis.

A 6-month double-blind study of OM-8980 and auranofin in 145 patients with rheumatoid arthritis was followed by an open observation period of 6 months for which 100 OM-8980-treated patients could be assessed. At the end of this second phase, the Ritchie index, number of swollen joints, pain scale, morning stiffness, grip strength and ESR had all improved further with respect to the significant improvements already recorded under OM-8980 and auranofin in the double-blind phase. The statistical analysis of the Ritchie index, pain scale and ESR showed significant changes in these 3 parameters during both the 6-month follow-up phase and the entire 12-month period. As regards the tolerance, 2 patients reported gastrointestinal disorders during the follow-up. The investigators' final assessment of efficacy indicated an improvement in 76% of the patients during the follow-up phase and in 95% during the entire 12-month period.

RCT Entities:   Population Interventions Outcomes