A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Simcere

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Iguratimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01554917

SIM-109

Details and patient eligibility

About

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

Full description

This is a multi-center, open, single arm study.

Enrollment: 1,759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,759 participants in 1 patient group

Iguratimod

Experimental group

Treatment:

Drug: Iguratimod