A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis

• Register: ChiCTR
• Last refreshed on: 16 December 2019
• Main ID: ChiCTR-IPR-15006081
• Date of registration: 2015-03-14
• Prospective Registration: No
• Primary sponsor: Xuan Wu Hospital, Capital Medical University
• Public title: A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis
• Scientific title: A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis
• Date of first enrolment: 2014-07-18
• Target sample size: prednisone group:15;Prednisone + methotrexate:15;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10563
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Contacts

• Name: Li Di
• Affiliation: Xuan Wu Hospital, Capital Medical University

• Name: Yuwei Da

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

myasthenia gravis

Intervention(s)

prednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate;

Primary Outcome(s)

Each group of total dose prednisone and average consumption;

Secondary Outcome(s)

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;

Source(s) of Monetary Support

Xuan Wu Hospital, Capital Medical University

Ethics review

Status: Approved
Approval date:
Contact: