Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Iguratimod 25mg: twice daily oral route for 26 weeks
Control Intervention1: Leflunomide 20mg: once daily oral route for 26 weeks
Sponsors
ChanRe Rheumatology and Immunology Center and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects of age of 18 to 65 years, both inclusive. 2. Subjects who had been diagnosed with active RA, according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for Rheumatoid Arthritis (ACR) criteria, and Disease Activity Score 28 (DAS28) greater than or equal to 3.2. 3. Tender joint count/swollen joint count =6. 4. Subjects meeting at least one of the following three conditions: erythrocyte sedimentation rate of at least 28 mm/hour, C-reactive protein (CRP) of at least 15 mg/liter 5. Patients who have failed the combination therapy, defined as subject who has failed to achieve remission after MTX+HCQ regime for 3 months. 6. Subject willing to sign informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Subjects treated with any biological injection within last 3 months. 2. Subjects with inadequate bone marrow function (defined as an absolute neutrophil count of not more than 2.5x10 to the power 9 per liter). 3.AST is greater than 1.5xULN (AST is equal to 10 to 34 IU per liter), AST greater than 1.5xULN (ALT is equal to 10 to 40 IU per liter). Cr is equal to 1.534 4. WBC is less than 4x10 to the power 9 per liter, HGB less than 85 grams per liter, PLT less than 100x10 to the power 9 per liter. 5. Subjects on current therapy of Iguratimod, Leflunomide, and Sulfasalazine, either separately or in combinations thereof. 6. Subjects receiving live vaccines within 3 months prior to study entry. 7. A history of hypersensitivity to any of the study drugs. 8. Pregnant women, nursing mothers and during treatment requirements of women of childbearing age. 9. Subjects with active gastrointestinal ulceration / bleeding, or history of peptic ulcers. 10. Subjects with known or suspected positive serology for human immunodeficiency, hepatitis B or C virus. 11. Subjects with history of any malignancies. 12. Subjects suffering from severe serious hepatic, cardiovascular, renal, hematologic or endocrine diseases. 13. Subjects who have participated in other clinical studies within 3 months. 14. Any condition which are likely to hinder the compliance with the protocol. 15. Subjects suffering under treatment of any chronic infection. 16. Subject with history of intra-articular infection within last four weeks. 17. Subjects with dosage of steroids more than 7.5mg/day. 18. Patients not on a stable dose of steroids for last 1 month. 19. Patients with significant systemic manifestations of rheumatoid arthritis. 20. Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes. 21. Any surgery of bone fractures within 8 weeks. 22. Malignancies i.e., solid or hematological. 23. Alcohol or drug abuse within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subject achieved the DAS 28 ESR score less than 2.6 Mean Reduction in Disease Activity Score 28 (DAS28) from baseline Timepoint: 3 time points | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the drugTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Devaraj Kori
Chanre Rheumatology and Immunology Center and Research
Outcome results
None listed