研究单位:[1]Chinese SLE Treatment And Research Group[2]the Affiliated Hospital of Kunming Medical University Kunming,Yunnan,China,650032[3]The First Affiliated Hospital of Bengbu Medical College Bengbu,Anhui,China[4]AnHui provincial hospital Hefei,Anhui,China[5]Nanfang Hospital Guangzhou,Guangdong,China[6]The Third Affiliated Hospital to SUN YAT-SEN University Guangzhou,Guangdong,China[7]The First Affiliated Hospital of Harbin Medcial University Haerbin,Heilongjiang,China[8]The first affiliated hospital of Zhengzhou University Zhengzhou,Henan,China[9]Minda Hospital of Hubei Province Enshi,Hubei,China[10]Jiangsu Province Hospital Nanjing,Jiangsu,China
研究目的:
This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate both in efficacy and safety.