This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
566
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Liuzhou workers' Hospital
Liuchow, Guangxi, China
ACR20 response rate at week 24
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
Time frame: Week 24
ACR20 response rate at week 52
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52
Time frame: Week 52
ACR50 response rate at week 24 and week 52
Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52
Time frame: Week 24 and week 52
ACR70 response rate at week 24 and week 52
Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52
Time frame: Week 24 and week 52
Change from baseline in HAQ-DI score at week 24 and week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52
Time frame: Week 24 and week 52
Change from baseline in SF-36 score at week 24 and week 52
Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52
Time frame: Week 24 and week 52
DAS28-CRP <2.6 proportion at week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6
Time frame: Week 24 and week 52
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DAS28-CRP≤3.2 proportion at week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2
Time frame: Week 24 and week 52