This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
418
SHR0302 tablets dose 1 for 48 weeks
SHR0302 tablets dose 2 for 48 weeks
SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks
Peking University Hospital
Beijing, Beijing Municipality, China
ACR20 response rate at week 24
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24
Time frame: Week 24
ACR20 response rate at week 48
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48
Time frame: Week 48
ACR50/70 response rate at week 24 and week 48
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 50%/70% (ACR50/70) at week 24 and week 48
Time frame: Week 24 and week48
Change from baseline in DAS28-CRP week 24 and week 48
Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48
Time frame: Week 24 and week 48
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