Myasthenia Gravis (MG) is an autoimmune disorder affecting the postsynaptic region of the neuromuscular junction (NMJ). Immunologically, MG is a heterogeneous group caused by pathogenic antibodies targeting key synaptic proteins.The clinical manifestations of Myasthenia Gravis (MG) include:Fatigue and Symptom Fluctuation: The severity of symptoms fluctuates, often depending on the level of activit
Conditions
Interventions
Group 1:Induction therapy from week 0 of enrollment with egamod 10mg/kg as an intravenous infusion for 1 hour, once a week for 4 weeks
After an interval of 1 week, tetatercept maintenance therapy was administered at a dose of 240mg once a week (qw) subcutaneously at week 5 of enrollment. A total of Tatasi was accepted General treatme
Group 2:Induction therapy from week 0 of enrollment with egamod 10mg/kg as an intravenous infusion for 1 hour, once a week for 4 weeks
After an interval of 2 weeks, tetanercept maintenance therapy was administered at a dose of 240mg, qw, subcutaneously at the 6th week of enrollment. A total of 24 weeks of tetatercept were treated.
Group 3:No induction therapy, maintenance treatment with tetanercept from week 0 of enrollment, administered at a dose of 240mg, qw, subcutaneously. A total of 30 weeks of tetatercept were treated.
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signed the informed consent form; 2. Age >=18 and =6 points, or myasthenia gravis quantitative score (QMG) of >=8 points, and maintained for more than 24 hours
Exclusion criteria
Exclusion criteria: 1. Combined with other active autoimmune diseases, such as SLE, rheumatoid arthritis, Sjögren's syndrome, etc.; 2. Patients with active infection, such as herpes zoster, HIV, active tuberculosis, active hepatitis; 3. Patients with thymoma within 6 months after surgery; 4. Patients with other malignant tumors other than thymoma; 5. Patients with severe hepatic and renal insufficiency, specifically defined as liver function: ALT or AST>3×ULN (upper limit of normal); Renal function: glomerular filtration rate GFR<30ml/min/1.73m2; 6.IgG<=400mg/dl; 7. Have used biological agents before enrollment and are within 5 times the half-life of the drug, such as tetatercept within 2 months before enrollment, agatimod within 1 month before enrollment, rituximab within 6 months before enrollment, etc.; 8. Use of intravenous immunoglobulin or plasmapheresis therapy within 2 months prior to enrollment; 9. Received any live vaccine within 3 months prior to the study or plans to receive any vaccine during the study; 10. Women who are pregnant or lactating and those who have a birth plan during the trial; 11. Allergy to human-derived biological products; 12. Participation in any clinical trial within 28 days prior to the study or within 5 times half-life of the investigational drug enrolled in the clinical trial; 13. Patients judged by other investigators to be unsuitable for enrollment (such as severe mental disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Quantitative Myasthenia Gravis (QMG) score from baseline at week 30; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline at weeks 4, 8, 12, 18, 24, and 30.;Proportion of patients achieving minimal status (MMS) at weeks 4, 8, 12, 18, 24, and 30.;Proportion of subjects in each group with a decrease of =2 points in MG-ADL score from baseline at weeks 4, 8, 12, 18, 24, and 30.;Proportion of subjects in each group with a decrease of =3 points in QMG score from baseline at weeks 4, 8, 12, 18, 24, and 30.;Change in the dose of corticosteroids and other immunosuppressants from baseline at weeks 24 and 30.;Proportion of patients who discontinued corticosteroids and other immunosuppressants at weeks 24 and 30;Proportion of patients with a prednisone (or equivalent corticosteroid) dose =5 mg/day at weeks 24 and 30.;Incidence of MG relapse/acute exacerbation and myasthenic crisis at week 30;Incidence of adverse events (AEs) and serious adverse events (SAEs) at week 30; | — |
Countries
China
Contacts
Public ContactXu Zhang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed