Myasthenia gravis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18-70 years, no gender restrictions; 2. Diagnosed with generalized Myasthenia Gravis (gMG) with a documented diagnosis and at least one of the following supporting evidence: a. History of neuromuscular transmission abnormalities confirmed by single-fiber electromyography or repetitive nerve stimulation; b. Positive response to neostigmine test. 3.Positive serological test for AchR antibodies; 4.Patients classified as MGFA clinical types II to V; 5. Refractory myasthenia gravis patients who show no improvement or worsening of the condition despite adequate doses and courses of corticosteroids or at least two immunosuppressants; refractory myasthenia gravis patients whose symptoms cannot be controlled by adequate doses of IVIG, PLE, or FcRN inhibitors; refractory myasthenia gravis patients with significant adverse drug reactions; 6.Subjects voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of psychiatric disorders or family history of such disorders; 2.History of malignancies other than thymoma, with evidence of recurrence within <=3 years; 3.Received IVIG or PLEX treatment within the past month, rituximab treatment within the past 6 months, eculizumab treatment within the past 2 months, or ravulizumab or other complement inhibitors within the past 3 months; 4.Presence of clinically significant active or chronic uncontrolled infections at the time of screening: history of recurrent invasive infections caused by encapsulated organisms (e.g., Neisseria meningitidis and Streptococcus pneumoniae); active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection; 5.Pregnant or breastfeeding patients, or those planning to become pregnant; 6. Any condition that the researcher believes may prevent the subject from completing the study or pose significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADL response rate in thymoma combined with MG and non-thymoma MG;QMG response rate in thymoma combined with MG and non-thymoma MG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prednisone reached a response rate of =5mg/ day;Serum AChR-ab difference; | — |
Countries
China
Contacts
Shijiazhuang People’s Hospital