Objectives:To prospectively study the efficiency of low-dose leflunomide in active rheumatoid arthritis with sulphasalazine.Methods:thirty-two subjects with active rheumatoid arthritis were randomized assigned to low dose leflunomide(omitting loading dose,maintenance dose10mg/day) or sulphasalazine for six months.The primary end-points were tender and swollen joint counts and global physician and patients assessments.Results:After six months,the mean changes in the low-dose leflunomide and sulphasalazine,respectively,were-9.7 and-8.3 for tender joint count(p0.05);-7.6 and-6.7 for swollen joint count(p0.05);-1.1 and-1.0 for physician global assessment(p0.05);-1.1 and-1.1 for patients global assessment(p0.05);the improved HAQ scores and C-reactive protein in leflunomide group were higher when comared with those of controlled group,while the ACR response in the two groups were comparable.The adverse events for patients received low-dose leflunomide were slightly except for two drug-related hypertension.Conclusion:Low-dose leflunomide used in the study were efficacious for active rheumatoid arthritis treatment compared with sulphasalazine,and it was well tolerated.