A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Criteria

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