Myasthenia gravis
Conditions
Interventions
group 1:High dose methylprednisolone shock therapy combined with immunosuppressants(methylprednisolone1000mg d1-2, 500mg d2-3,250mg d4-5, 125mg d6-7,80mg d8-9,60mg d10-11,10mg d12-13)
group 2:On the basis of 1000mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with the application of Vyvgart.
group 3:On the basis of 1000mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with IVIG.
group 4:On the basis of 1000mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with PE.
group 5:High dose methylprednisolone shock therapy combined with immunosuppressants(methylprednisolone 500mg d2-3,250mg d4-5, 125mg d6-7,80mg d8-9,60mg d10-11,10mg d12-13)
group 6:On the basis of 500mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with IVIG.
group 7:On the basis of 500mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with PE.
group 8:On the basis of 500mg methylprednisolone shock therapy combined with immunosuppressive agents, combined with the application of Vyvgart.
Sponsors
Shijiazhuang People’s Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Age 18 and above; 2)According to the evaluation of the thoracic surgery or neurology physicians at our center, MGFA is classified as a type IIb-V patient with myasthenia gravis;Patients who have been determined by clinical doctors to be suitable for high-dose glucocorticoid shock therapy. 3)For women with reproductive potential: agree to use appropriate contraceptive measures during treatment and at least 3 months after receiving the last dose of Egamode; 4)Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1)Study subjects who are known to be allergic to any component of the investigational drug or any other anti neonatal FcRn drug; 2)According to the researcher's assessment, the study participants have clinically significant active infections (including untreated or insufficiently treated infections); 3)The total IgG level of the study subjects during screening visits is = 6 g/L 4)Patients with severe underlying diseases such as heart failure, arrhythmia, and coagulation dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative Myasthenia Gravis score;activities of daily living; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in lymphocytes;Changes in antibodies against myasthenia gravis;Changes in IgG; | — |
Countries
China
Contacts
Public ContactQi Guoyan
Shijiazhuang People’s Hospital
Outcome results
None listed