This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
Time frame: week 52
Change from baseline in modified Total Sharp Score (mTSS)
Time frame: week 52
Percentage of patients with ACR 50 response and ACR70 response
Time frame: week 24,week 52
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)
Time frame: week 24, week 52
Time to achieve the ACR20, ACR50 and ACR70
Time frame: week 12, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
Time frame: week 12, week 24, week 40, week 52
Incidence of adverse events
Time frame: up to 52 weeks
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