Rheumatoid arthritis
Conditions
Interventions
Group A:leflunomide 10mg,orally taken once daily for 24 weeks
Group B:leflunomide 50mg, orally taken weekly for 24 weeks
Sponsors
People's Hospital, Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 65 years old; 2. Able and willing to provide signed informed consent; 3. Early rheumatoid arthritis patients with clinical Mild and Moderate active disease.Diagnosis was based on the 1987 revised American College of Rheumatology(ACR) criteria for RA: (1) Morning stiffness>=1h; (2) Arthritis of three or more joint areas, >=6 weeks; (3) Arthritis of hand joints, >=6 weeks; (4) Symmetric arthritis, >=6 weeks; (5) Rheumatoid nodules; (6) Serum rheumatoid factor; (7) Radiographic changes. Satisfied at least four of these seven criteria; 2. Disease duration equal to or less than 1 year; 3. Clinical Mild and Moderate active disease. Define as the DAS28 score between 2.6 and 5.1. 4. The X-ray of hands between stage I and II.
Exclusion criteria
Exclusion criteria: 1. Allergic to leflunomide; 2. Inefficiency to leflunomide; 3. Patients who had any disease modifying antirheumatic drug within 3 months before enrolment; 4. Patients who had biologics within 1 month before enrolment; 5. A history of intra articular or intramscular injection with glucocorticoids within 1 month before enrolment; 6. Patients who had glucocorticoids = 7.5mg/d within 1 month before enrolment; 7. A history of haematological disorders or abnormal of blood test(white blood cell count less than 4*10^9/L, or platelet less than 100*10^9/L); 8. A history of chronic hepatitis; 9. Any history of hepatic and renal damage(transaminase elevated ; serum creatinine>1.5mg/dl); 10. A history of active infection during enrolment; 11. Alcohol abuse within 2 years; 12. Pregnancy and breast feeding women or who were plan to pregnant within 1 years; 13. A history of malignant neoplasms; 14. Severe hpertension or cardiopulmonary dysfunctions; 15. A history of epilepsy and other abnormalities of nervous system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The doctor's and the patient's overall assessment;Sharp score;Lab test;Arthralgia visual analog scale and joint swollen;Score of health assessment questionnaire;Improvement of clinical symptoms and signs; | — |
Countries
China
Contacts
Public ContactZhanguo Li
Outcome results
None listed