Refractory myasthenia gravis
Conditions
Interventions
Interventions group:The initial dose is 9 µ g, administered intravenously continuously for 5 days, with a total dose of 38.5 µ g. After stopping the medication for one week, the patient received a sec
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old =6 points and persists for at least half a year; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the PIS is in remission or improvement, yet during the regular tapering of immunotherapeutic drugs, there are still at least two annual exacerbations of disease symptoms (MG-ADL score >=6 points); or after the occurrence of a crisis, despite multiple immunotherapies such as intravenous immunoglobulin, plasmapheresis, and high-dose intravenous methylprednisolone, and active infection control, the patient still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days (4) positive for anti-AChR, and/or anti-MuSK, and/or anti-LRP4 antibodies (5) patient or their legal representative signs an informed consent form in writing
Exclusion criteria
Exclusion criteria: (1) pregnant or lactating women (2) individuals with an allergy to Blinatumomab (3) individuals who have undergone thymectomy within the 12 months prior to baseline or who are planning to have a thymectomy during the 12-week study period (4) individuals who have received biologic agents targeting CD19 or CD20 within 6 months prior to baseline are eligible for enrollment (subjects with CD19 or CD20 positive B cell counts above the lower limit of normal are allowed to participate) (5) within the 3 months prior to baseline, use of Ecuzumab and Tocilizumab (6) received intravenous immunoglobulin or plasma exchange therapy within 4 weeks prior to baseline (7) currently participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myasthenia Gravis-Activities of Daily Living Scale Score changes at week 12;steroid dosage change;whether to undertake remedial treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative Myasthenia Gravis Score changes at week 12;Adverse Events;Myasthenia Gravis-Activities of Daily Living Scale Score changes at week 24;Myasthenia Gravis Composite changes at week 12;15 Revised Quality of Life Scales for Myasthenia Gravis score changes at week 12;minimal symptom expression; | — |
Countries
China
Contacts
Public ContactQingwu Yang
Second Affiliated Hospital of Army Medical University
Outcome results
None listed