ObjectiveTo observe the clinical efficacy and safety of methotrexate (MTX) combined with iguratimod for patients with active rheumatoid arthritis (RA).MethodsA total of 60 patients with active RA were divided into two groups randomly: the treatment group (n=30) treated with MTX 10 mg once a week and iguratimod 25 mg twice a day, and the control group (n=30) treated with MTX 10 mg once a week together with tripterygium glycosides 20 mg three times a day for 12 weeks.The clinical efficacy and the incidence of adverse reactions of the both groups were evaluated at the 0, 4 th, 8 th, and 12 th week.ResultsThe disease activity score (DAS) 28 of the two groups were significantly improved at the 4 th, 8 th and 12 th week.Compared with the control group, the improvement of DAS28 in the treatment group at the 8 th week was statistically significant [(2.78±1.25) vs （3.25±1.56），P<0.05].The erythrocyte sedimentation rate(ESR), C-reactive protein (CRP) and other indexes decreased significantly in both groups after 12 weeks of treatment and the levels of Rheumatoid Factor（RF）, and immunoglobulin （IgG，IgM） in treatment group were significantly decreased than those before treatment and than those in control group (P<0.05).No serious adverse reactions occurred in both groups.ConclusionMTX combined with iguratimod for patients with active RA has better clinical efficacy and safety.