Rheumatoid Arthritis
Conditions
Interventions
Group B:MTX 7.5-20mg, orally taken once weekly for 48 week
Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks
Sponsors
People's Hospital, Peking University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 years old and over; 2. RA patients with active disease; 1) Diagnosis is 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) The definiation of active disease is as follows: (1) Moderate pain at rest; (2) Morning stiffness of 1 hour or longer; (3) Three or more swollen joints; (4) Five or more tender joints; (5) Westergren's erythrocyte sedimentation rate(ESR) of 28mm or more in the first hour. 3. joint function on III-IV stage; 4. Able and willing to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Joint function in Stage IV according to the American College of Rheumatology(ACR); 2. Allergic to Bisphosphonates; 3. Bed ridden, unable to remain standing; 4. A history of active ulcer or active inflammatory bowel disease; 5. A history of gastro-esophageal reflex disease; 6. Severe periodontitis; 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. Any history of severe hepatic disease (ALT or AST is elevated more than 3 times) and severe renal insufficiency; 9. Alcohol abuse within 2 years; 10. A history of malignant neoplasms except appropriate therapy of basal cell carcinoma and Other tumors has been successfully treated more than 5 years and no evidence of recurrence; 11. Severe hpertension or cardiopulmonary dysfunctions; 12. A history of epilepsy and other abnormalities of nervous system; 13. Pregnancy and breast feeding women; 14. Women who have the requirement of fertility; 15. Join in other Clinical trials within 4 weeks during enrolment; 16. Patients who had glucocorticoids >=10mg/d within 1 month before enrolment; 17. Patients who had any other disease modifying antirheumatic drug within 2 months before enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SHARP score; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS 28 score;Improvement of clinical symptoms and signs;Laboratory Examination;The doctor's and the patient's self assessment; | — |
Countries
China
Contacts
Public ContactZhanguo Li
Outcome results
None listed