OBJECTIVE： To observe clinical efficacy and safety of iguratimod combined with methotrexate in the treatment of rheumatoid arthritis. METHODS： A total of 82 patients with rheumatoid arthritis selected from our hospital from Feb. 2015 to Feb. 2016 were randomly divided into observation group and control group， with 41 cases in each group. Control group was given Methotrexate tablets 10 mg orally， once a week， increasing to 15 mg 2 weeks later， once a week. Observation group was addtionally given Iguratimod tablets 25 mg orally after meal， bid， on the basis of control group. Treatment course of 2 groups lasted for 6 months. Clinical efficacies and the occurrence of ADR were observed in 2 groups. The joint tenderness count， joint swelling count and morning stiffness time were also observed before and after treatment. The erythrocyte sedimentation rate， CRP， platelet count， serum immunoglobulin （IgG， IgA and IgM） and T lymphocyte subsets （CD3+， CD4+ and CD8+） levels were detected in 2 groups before and after treatment. RESULTS： The total response rate of observation group was 90.24％， which was significantly higher than 78.05％ of control group， with statistical significance （P＜0.05）. Before treatment， there was no statistical significance in above indexes between 2 groups （P＞0.05）. After treatment， the number of joint tenderness and joint swelling in 2 groups were significantly lower than before treatment， and the time of morning stiffness was significantly shorter than before treatment. The erythrocyte sedimentation rate， CRP， platelet count， serum immunoglobulin and T lymphocyte subsets were significantly lower than before treatment. The observation group was significantly lower than the control group， with statistical significance （P＜0.05）. No obvious ADR was found in 2 groups. There was no statistical significance in the incidence of ADR between 2 groups （P＞0.05）. CONCLUSIONS： Compared with methotrexate alone， iguratimod with methotrexate can improve therapeutic efficacy， relieve clinical symptom and inhibit immune function so as to control the progression of rheumatoid arthritis with good safety.