Abstract: Objective To evaluate the efficacy and safety of recombinant human tumor necosis factor-Fc fusion protein (rh TNFR:Fc)(etanercept) in combination with methotrexate (MTX) for the treatment of early rheumatoid arthritis(RA).Methods A total of 32 patients with active early RA were randomly divided into the treatment group (n=22) and the control group (n=10).The former was treated with rh TNFR:Fc (injected with 25mg subcutaneously,twice a week) along with oral MTX (7.5-15mg/w);the latter was treated with MTX only.The whole course lasted 24 weeks and the curative effect was statistically evaluated by the United States Institute of Rheumatology (ACR) 20,ACR50 and ACR70 improvement criteria 4,8,12 and 24 weeks after treatment. Meanwhile, adverse events were recorded and evaluated.Results Thirty participants completed the trial and 2/3 of them were in the treatment group.At the 4th,8th,12th and 24th week,the ACR20,ACR50,ACR70 effective rates of the treatment group were respectively higher than those of the control group and the difference between the two groups was significant (P<0.05 or P<0.01).Twenty four weeks after treatment,approximately 77.27% (17／20) patients in the treatment group and 2 patients in the treatment group developed infection,but no severe adverse effect was encountered.Conclusion Etanercept combined with methotrexate had accurate curative effect in the treatment of active early RA and its short-term clinical effect was superior to that of methotrexate used alone. Its most common adverse effect was infection.