myasthenia gravis
Conditions
Interventions
prednisone group:prednisone
Prednisone + methotrexate:Prednisone + methotrexate
Sponsors
Xuan Wu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 18 years old, male or female; 2. MGFA level 2, 3, or 4 MG; 3. Higher AChR - Ab or does not rise, not affect patient signs and symptoms of other illnesses; 4. Prednisone dose for at least 10 mg/day, there must be a stable patients taking prednisone 30 days before the screening; 5. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Chronic degenerative disease, mental disease or neurological disease can produce MG were unable to exclude; 2. the main chronic or other debilitating diseases within six months before enrolment of the study; 3. Premenopausal women with serum pregnancy test positive;Lactation; Without effective birth control method; 4. The disturbance of consciousness, dementia, or abnormal mental state; 5. Thymoma; 6. 3 months underwent thymus resection surgery; 7. Patients taken azathioprine in 2 months, cyclophosphamide, cyclosporin, mycophenolate mofetil, intravenous immunoglobulin, or other immunosuppressive drugs; 8. The X-ray show tumor, infection or interstitial lung disease; 9. The history of a chronic or recurrent infection; 10. Every day use of non-steroidal anti-inflammatory drugs (nsaids); 11. A history of renal or hepatic insufficiency or liver enzyme is higher than normal level; 12. The bone marrow hypoplasia, leucopenia, thrombocytopenia, anemia , history of clinical or laboratory evidence of immune deficiency syndrome; 13. Forced vital capacity (FVC) <50% forecast; 14. MG1 grade or level 5; 15. Before using methotrexate for any reason; 16. 4 weeks before the start of this study had participated in other clinical trials; 17. Hypertension and (or) diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each group of total dose prednisone and average consumption; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of quantitative MG compared to the baseline score;The initial improve duration;Frequency of adverse events;Treatment failure;The quality of life evaluation; | — |
Contacts
Public ContactYuwei Da
Outcome results
None listed