generalised myasthenia gravis
Conditions
Interventions
observation group:On the basis of keeping the original myasthenia gravis treatment unchanged, the patients will be given Efgartigimod intravenous infusion (10mg/kg) once a week for 4 weeks
Sponsors
Hainan General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients aged at least 18 years with generalised myasthenia gravis, with or without acetylcholine receptor antibodies, were eligible if their disease was categorised as Myasthenia Gravis Foundation of America class II to IV and they had a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 5 (with >50% of the MG-ADL score due to non-ocular symptoms). Eligibility criteria also required patients to be on a stable dose of at least one treatment for generalised myasthenia gravis (ie, acetylcholinesterase inhibitors, corticosteroids, or NSISTs) before screening and throughout the trial.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had received rituximab or eculizumab in the 6 months before screening, undergone thymectomy within 3 months, had intravenous immunoglobulin or plasma exchange within 1 month of screening, had active hepatitis B, were seropositive for hepatitis C, seropositive for HIV with low CD4 count, had serum IgG levels less than 6 g/L at screening, or were pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in MG-ADL from baseline after 4 weeks of Efgartigimod treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| QMG reduction from baseline after 4 weeks of Efgartigimod treatment;Reduction in MG-QoL15r from baseline after 4 weeks of Efgartigimod treatment;Reduction in total IgG and AChR antibodies from baseline after 4 weeks of Efgartigimod treatment;Reduction in MG-ADL from baseline at the end of the study (8 weeks);Reduction in QMG from baseline at the end of the study (8 weeks);Reduction in MG-QoL15r from baseline at study end (8 weeks); | — |
Countries
China
Contacts
Public ContactShixiong Huang
Hainan General Hospital
Outcome results
None listed