The issues in the critical inclusion and exclusion criteria for new drug clinical trials on ankylosing spondylitis
10.3760/cma.j.cn141217-20230105-00006
- VernacularTitle:国内强直性脊柱炎药物临床试验关键入排标准的设计考量
- Author:
Yanfei MU
1
;
Xiaoxia WANG
;
Peihan WU
;
Xiaoqi MAO
;
Yanchun CHI
;
Tao HAN
;
Meilin YIN
Author Information
1. 山西医科大学第二医院风湿免疫科，太原 030001
- Keywords:
Spondylitis, ankylosing;
Pharmaceutical preparations;
Clinical trial protocol
- From:
Chinese Journal of Rheumatology
2024;28(9):656-659
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze and summarize the key points of design and implementation of new drug clinical trials for ankylosing spondylitis.Methods:The platform for drug clinical trial registration and information published on the official website of center for drug review and evaluation of national medical products administration (CDE) was searched to obtain data and classified statistics was conducted then. The Mean±SD and M ( Q1, Q3) were used for quantitative data for statistical description, and the rate, composition or relative ratio of qualitative data were used for statistical description. Results:A total of 23 clinical trials meeting the requirements were screened, among which 19 were biological products included in nine phase Ⅲ clinical trials. Among the four chemical drugs, two were phase Ⅱ clinical trials. One of the clinical trials on AS adopted the 1966 New York classification criteria, accounting for 4%. Nineteen of the trials adopted the1984 New York classification criteria, accounting for 83%. Three other trials adopted unspecified classification criteria, accounting for 13%. In one of these clinical trials, the age of patients included was older than 16 years old, 9 trials were 18 to 65 years old, 6 were 18 years old but without upper limit. In the definition of active AS, 19 trials took BASDAI≥4 as the cut-off value for active disease, and BASDAI, total back pain, spinal pain and morning stiffness were regarded as active disease in 4.Conclusion:The number of dosestic AS clinical trial projects continnes to rise. The 1984 classification criteria is adopted as the classification criteria in clinical trials. The minimum age in the inclusion criteria is 18 years old, there is no upper limit in age for inclusion. Disease activity can be evaluated by BASDAI score, combined with comprehensive indicators such as night-time back pain, global spinal pain and morning stiffness.
