To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
Peking Union Medical College Hospital
Beijing, China
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
Time frame: Baseline - Week 24
Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 12
Time frame: Baseline - Week 12
Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 24
Time frame: Baseline - Week 24
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
Time frame: Baseline - Week 12
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
Time frame: Baseline - Week 24
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