This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.
This is a multi-center, open, single arm study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,759
taken orally, 2 tablets/day (bid)
Peking University People's Hospital
Beijing, China
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
Time frame: week 24
Incidence of adverse events
Time frame: up to 28 weeks
Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)
Time frame: week 24
Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)
Time frame: week 24
Change from baseline in Disease Activity Score 28 (DAS28)
Time frame: week 24
Change from baseline in Health Assessment Questionnaire (HAQ)
Time frame: week 24
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