Myasthenia gravis
Conditions
Interventions
Efgartigimod Group:Efgartigimod 10 mg/kg IV every 1 week for 4 consecutive weeks, with an interval of 2 to 4 weeks between courses.
Ig Group:IVIg is applied on the basis of basic treatment.Specific usage of IVIg: patients are given 400 mg/(kg-d) intravenously once a day for 5 days.
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. Confirmed diagnosis of myasthenia gravis (MG); 3. Significant progression of bulbar or respiratory muscle symptoms within the past two weeks; 4. MGFA IVb classification, or MG quantitative score of 3 points for bulbar muscles or 2 points for respiratory muscles, or a combined bulbar and respiratory muscle score >= 4 points; 5. Regular follow-up appointments; 6. Voluntary participation in this study and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Positive serological antibodies for hepatitis B, hepatitis C, or HIV, or detection of active viral infection 2. History of any known bacterial, viral, or fungal infection within the preceding 8 weeks, or infection requiring hospitalisation/intravenous antimicrobial therapy 3. Low serum IgG levels (< 6 g/L) 4. Pregnant or breastfeeding women, or those planning pregnancy 5. Previous vaccination within the preceding 4 weeks (e.g., influenza vaccine) 6. Patients with clinical evidence of other significant illnesses or recent major surgery, where trial results may be confounded or patients exposed to undue risk. Patients with renal/hepatic impairment may be eligible. 7. Patients with a history of malignancy (including malignant thymoma or myeloproliferative or lymphoproliferative disorders), unless considered cured with no evidence of recurrence for =3 years following adequate treatment prior to screening. Patients with completely excised non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ may be enrolled at any time. 8. Other subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MG-ADL score;QMG score;Probability of successful rescue of IMC; | — |
Secondary
| Measure | Time frame |
|---|---|
| MG-QOL-15; | — |
Countries
China
Contacts
Public ContactYang Xiao
General Hospital of Ningxia Medical University
Outcome results
None listed