Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Leflunomide; Methotrexate

Criteria

Inclusion Criteria:

• Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)

• Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis

• Functional Class II-III

• Subjects have active RA at the time of screening

• Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.

• For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2

• Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline

• Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr

• Must have a negative Pregnancy test and use adequate method of contraception throughout the trial

• Written informed consent

Exclusion Criteria:

• Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry

• Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.

• Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.

• Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.

• ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN

• WBC<4×109/L，HGB<85g/L，PLT<100×109/L

• Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant

• Women of Pregnant or breastfeeding, and male or female with recent plan to conception

• Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease

• Allergic to any of the study drugs

• History of alcoholism

• Subjects with mental illness

• Subjects receiving live vaccines recently

• Subjects participating in other clinical study within 3 months prior to study entry