Myasthenia gravis
Conditions
Interventions
Sponsors
Eligibility
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-IVb patient with myasthenia gravis; 3) MG patients who undergo thymectomy on a scheduled basis have no contraindications for surgery or anesthesia; 4) 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; 5) 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 |
|---|---|
| myasthenia gravis foundation of America;The proportion of patients who successfully underwent tracheal intubation within one day after thymic surgery and did not undergo tracheal intubation again within one week; | — |
Secondary
| Measure | Time frame |
|---|---|
| activities of daily living;Quantitative Myasthenia Gravis score;Changes in antibodies against myasthenia gravis;Changes in lymphocytes;Changes in IgG; | — |
Countries
China
Contacts
Shijiazhuang People’s Hospital