This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
910
25 mg/tablet, taken orally, 2 tablets/day (bid)
2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Percentage of patients with ACR 20 response
Time frame: week 52
Change from baseline in modified Total Sharp Score (mTSS)
Time frame: week 52
Change from baseline in mTSS
Time frame: week 24
Percentage of patients achieving radiographic non-progression
Time frame: week 24, week 52
Percentage of patients with ACR 20 response
Time frame: week 12, week 24, week 40
Percentage of patients with ACR 50 response
Time frame: week 12, week 24, week 40, week 52
Percentage of patients with ACR 70 response
Time frame: week 12, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
Time frame: week 12, week 24, week 40, week 52
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 2 years
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