A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

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.

Inclusion Criteria:

• Subjects with a diagnosis of RA
• Subjects who have active RA at the time of screening
• Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
• Written informed consent

Exclusion Criteria:

• Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
• Pregnant or lactating women
• ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L
• WBC<4×109/L，HGB<85g/L，PLT<100×109/L
• Subjects with uncontrolled infection
• Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
• Allergic to any of the study drugs
• History of alcoholism
• Subjects receiving live vaccines within 3 months prior to study entry
• Subjects participating in other clinical study within 3 months prior to study entry