Analysis of drug clinical trials for rheumatic diseases in China
10.3760/cma.j.cn141217-20191216-00424
- VernacularTitle:我国风湿性疾病药物临床试验现状分析
- Author:
Xiaoxia WANG
1
;
Hong WANG
;
Jiali HE
;
Dan LIU
;
Peihan WU
;
Guihai LIU
Author Information
1. 山西医科大学第二医院药物/医疗器械临床试验机构办公室 太原，030001
- From:
Chinese Journal of Rheumatology
2020;24(4):240-246
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze and summarize the drug registration clinical trial for rheumatic diseases in China from January 2013 to November 2019.Methods:The website of CDE was searched to obtain the data and statistical analysis was conducted.Results:①The number of drug clinical trials for rheumatic diseases in China increased year by year and the total was 525. The registered indications mainly included diffuse connective tissue disease, spondylo arthritis, metabolic diseases and degenerative diseases, including rheumatoid arthritis (RA) (189), gout (122), osteoarthritis (OA) (89), ankylosing spondylitis (AS) (60) and systemic lupus erythematosus (SLE) (39). ② The phaseⅡ-Ⅲ clinical trials were mainly for biological disease-modifying antirheumatic drugs (bDMARDs). Most of the bioequivalence test (BE) were chemical drugs.③ The domestically developed chemicals and biological included BLyS/APRIL, CD22, JAK1, S1P1 and BTK. ④ Adalimumab and tocilizumab accounted for the largest proportion of biosimilar drugs. The indications were mainly RA. ⑤ The number of international multi-center clinical trials increased year by year, with the indications mainly for RA and SLE.Conclusion:① The overall number of drugs trials for rheumatic diseases in China has been increasing rapidly in recent years. ② The research and development of chemicals and biologics is the trend. ③ Significant achievements have been made in the research and development of biosimilars in China and it is expected to benefit more patients by broaden the indications.
