ObjectiveTo explore the clinical effect and safety of iguratimod (T-614) combined with methotrexate ( MTX) in the treatment of rheumatoid arthritis(RA). Methods60 patients with RA were randomly divided into experimental group and control group according to random number table,30 cases in each.Control group was treated with oral MTX, 15 mg per time, once a week, while experimental group was treated with iguratimod on the based of control group, the treatment of iguratimod was 25mg per time after meals , b. i. d .The treatment course of both groups were 12 weeks. The joint swelling, pain relief, the changes of the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), the rheumatoid factor (RF), anti-cyclic citrullinated peptide (CCP) antibodies as well as other indicators and the occurrence of the adverse reaction of the two groups were observed before and after treatment. The ratio of ACR20, ACR50, ACR70 between the two groups were calculated and compared based on the above index. ResultsAfter 12 weeks of treatment, the clinical symptoms, signs and laboratory parameters were significantly improved in the two groups. The effective rate of ACR20,ACR50,ACR70 in experimental group were 83.33%, 66.67%,53.33%and 50.00%,36.67%,26.67% in control group,respectively. The clinical efficacy of the experimental group was better than that in the control group and the difference was statistically significant (P＜0.01 or P＜0.05). Both of the two groups had no serious adverse events,and the incidence of adverse reactions between two groups was no significant difference (P＞0.05). ConclusionsT-614 combined with MTX show a good clinical efficacy and security in the treatment of RA,which is better than MTX treatment alone and should be widely applied.

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