Myasthenia gravis
Conditions
Interventions
The standard treatment group: The control group received standard treatment for myasthenia gravis, excluding Ocrelizumab therapy
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Voluntary signing of informed consent by the patients. 2. Diagnosis of AchR antibody-positive generalized MG meeting the following criteria: - Presentation of weakness in certain specific striated muscle groups with patchy distribution, characterized by fluctuation and fatigability. - Symptoms of weakness are worse in the morning and improve after rest; exacerbation after sustained activity and relief/improvement after rest. - Positive result on the neostigmine test (quantitative assessment method by Edrophonium). - and/or Electromyography (EMG) examination: - Repetitive nerve stimulation (RNS) test showing a decrement of more than 10% in amplitude with low-frequency stimulation on at least one nerve, or Single Fiber Electromyography (SFEMG) showing widening of two or more "jitter" measurements. - Exclusion of other syndromes causing weakness, such as Guillain-Barré syndrome, Lambert-Eaton myasthenic syndrome, etc. - Patients must have received treatment with two or more immunosuppressive therapies, or at least one immunosuppressive therapy with at least four intravenous injections of immunoglobulin or plasma exchange per year for 12 months without symptom control. 3. Positive serum AChR-Ab test. 4. Clinical classification according to the Myasthenia Gravis Foundation of America (MGFA): II (including IIa and IIb), III (including IIIa and IIIb), or IVa. 5. Myasthenia Gravis Activities of Daily Living (MG-ADL) score = 6, and ocular-related score less than 50% of the total score. 6. Quantitative Myasthenia Gravis (QMG) score = 8, with at least 2 points in at least 4 items. 7. Maintenance of stable standard treatment regimen, which includes stable use of any one or combination of the following: a. Acetylcholinesterase inhibitors: Stable use for at least 2 weeks prior to the start of the clinical trial, with a dose = 480 mg/day. b. Corticosteroids: Prednisone dose = 40 mg/day or equivalent steroid, maintained for at least 1 month before the start of the clinical trial. c. Immunosuppressants: - Azathioprine: Initiated at least 6 months prior to the start of the trial, and the dosage maintained stable for at least 3 months before the trial. - Mycophenolate mofetil: Maintained stable for at least 3 months before the trial. - Methotrexate: Maintained stable for at least 3 months before the trial. - Cyclosporine or tacrolimus: Maintained stable for at least 3 months before the trial.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Concomitant autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, etc., except for patients with Graves' disease or hypothyroidism as evaluated by the investigator. 2. Significant abnormalities in laboratory indicators (e.g., markedly elevated creatinine). 3. Use of immunosuppressive agents other than standard treatment within the month preceding the clinical trial. 4. Use of biologics targeting therapy, such as Rituximab, complement C5 inhibitors, within 6 months before the clinical trial. 5. Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin, or plasma exchange therapy within 2 months before the clinical trial. 6. Presence of significant cardiovascular diseases (including severe arrhythmias), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition deemed by the investigator to interfere with the subject's participation in the study or require hospitalization during the study. 7. Presence of acute or chronic infections requiring treatment, as follows: - Receipt of any anti-infective therapy (such as for tuberculosis, Pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria) within the 4 weeks prior to baseline. - Hospitalization for anti-infective therapy within 60 days prior to baseline. - Occurrence of infections requiring intravenous antibiotics (antibacterial, antiviral, antifungal, or antiparasitic) within 60 days prior to baseline. 8. Current active hepatitis or history of severe liver disease. For hepatitis B: exclusion of patients with positive HBsAg. For patients with negative HBsAg but positive HBcAb, HBV-DNA testing is required to determine eligibility: patients with positive HBV-DNA are excluded from the study, while those with negative HBV-DNA can participate. For hepatitis C: exclusion of patients with positive hepatitis C antibodies. 9. Patients with positive HIV antibodies. 10. Patients with positive test results for COVID-19 infection within the 4 weeks preceding screening. 11. Patients with a history of severe COVID-19 requiring hospitalization within the 12 months preceding screening. 12. Poorly controlled diabetic patients: glycosylated hemoglobin > 9.0% or fasting blood glucose = 11.1 mmol/L. 13. Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome), or those who have undergone thymectomy within 6 months before screening. 14. Receipt of or planned receipt of any live vaccines or COVID-19 vaccines (including nasal spray) within the 3 months before the start of the study. 15. Patients with malignant tumors. 16. Known allergy to human-derived biologics. 17. Participation in any other clinical trial within 28 days prior to the start of the study or within 5 times the half-life of investigational drugs used in clinical trials (whichever is longer). 18. Pregnant or lactating women, or patients planning to conceive during the trial. 19. Known alcohol or drug abuse/addiction that may affect compliance with trial requirements. 20. Patients deemed unsuitable for participation in the trial by the investigator (e.g., severe psychiatric disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in MGFA-QMG score from baseline to Week 24;The change in MG-ADL score from baseline to Week 24;The change in MG-QOL15r score from baseline to Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with a decrease of =3 points in MG-ADL score from baseline at Weeks 12 and 2;he proportion of subjects with a decrease of =5 points in QMG score from baseline at Weeks 12 and 24;The effect of corticosteroid reduction in MG patients at Week 24;The percentage of subjects experiencing treatment-related adverse reaction; | — |
Countries
China
Contacts
Public ContactZhaoxu Zhang
Peking University People's Hospital
Outcome results
None listed