Generalized Myasthenia Gravis
Conditions
Interventions
Group 1(Plasma Exchange + Efgartigimod):Plasma Exchange (PE) for 3-5 times followed by 3 cycles of Efgartigimod (10mg/kg, qweek *4 cycles)
Group 1((Plasma Exchange Only):Plasma Exchange (PE) for 3-5 times only
Group 1(Efgartigimod Only):Efgartigimod (10mg/kg, qweek *4 cycles) for 3 cycles
Sponsors
Punan Hospital in Pudong New District, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years; (2) Newly diagnosed (within 1 month of confirmation) and treatment-naive AChR-Ab+ gMG patients; (3) Myasthenia Gravis Activities of Daily Living (MG-ADL) score >=5; (4) Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV; (5) Plan to use PLEX and/or Efgartigimod; (6) Plan to use NSIST including AZA, MMF and TAC; (7) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: (1) Prior monoclonal antibody biologics administration (e.g., rituximab, eculizumab), NSIST within 6 months pre-enrollment; (2) Live vaccine exposure<=3 months pre-trial or planned vaccination during study period; (3) Intravenous immunoglobulin (IVIG) infusion or PLEX <= 4 weeks pre-screening; (4) Patients who have received corticosteroids within the past week; (5) Active hepatitis B infection (HBsAg+ or HBV DNA+); (6) Hepatitis C or HIV seropositivity; (7) Hypogammaglobulinemia (serum IgG < 4.5 g/L); (8) pregnancy/lactation status, or pregnancy planning during trial; (9) Concomitant autoimmune comorbidities (e.g., systemic lupus erythematosus, rheumatoid arthritis); (10) Hypersensitivity to human plasma-derived biologics; (11) history of thymoma or thymectomy; (12) Investigator-assessed ineligibility due to clinical/safety concerns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved MSE; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who experiences acute exacerbation in remission phase;The average changes in MG-ADL and QMG scores compared to baseline at weeks 4, 8, 12, 16, 20, and 24;The average time to reach MSE for the first time;The incidence and severity of adverse events (evaluated by CTCAE grading);Proportion of patients who do not use corticosteroids;Proportion of patients who do not use cholinesterase inhibitors;Cholinesterase inhibitors and oral corticosteroids dosage, as well as cumulative hormone dosage during the visit period;Changes in AChR-Ab, immunological indicators such as serum lymphocytes and cytokines relative to baseline at week 24; | — |
Countries
China
Contacts
Public ContactYangtai Guan
Punan Hospital in Pudong New District, Shanghai
Outcome results
None listed