Generalized myasthenia gravis
Conditions
Interventions
Control group:NA
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, and voluntarily sign the informed consent form; 2. Meet the diagnosis of myasthenia gravis and satisfy at least 2 of the following conditions: (1) Positive for AChR-Ab or MuSK-Ab; (2) Positive for repetitive electrical stimulation; (3) Positive for neostigmine test; 3. MGFA classification is II-III; 4. New-onset gMG, defined as generalized symptoms appearing within 1 year of onset (no time limit for ocular symptoms); 5. Have not received steroid hormone treatment or have received a stable dose of steroid hormone treatment (the dose did not change within 1 month before screening, and was within 10-20mg); 6. If the patient is receiving AChE inhibitor treatment, the following criteria must be met: The dose was stable within 2 weeks before screening, and there was no dose increase; 7. QMG score >= 8 points and the score of 4 or more items of QMG is >= 2 points, or MG-ADL score >= 5 points (eye symptom score < 50%).
Exclusion criteria
Exclusion criteria: 1. Those who have received non-steroidal immunosuppressive agents (such as azathioprine, methotrexate, cyclosporine, tofacitinib, tacrolimus, mycophenolate mofetil, and cyclophosphamide, etc.) and have not stopped taking the medication for less than 3 months before screening; 2. Those with autoimmune diseases and in active disease stage (mainly based on blood sedimentation rate/CRP as the reference indicators), such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, etc., excluding hypothyroidism and hyperthyroidism; 3. Those who received targeted therapy with anti-CD20 monoclonal antibodies within 6 months before screening; 4. Those who received other monoclonal antibodies except anti-CD20 monoclonal antibodies within 1 month before screening; 5. Those who received intravenous immunoglobulin treatment or plasma exchange treatment within 1 month before screening; 6. Those with malignant tumor history or tumor recurrence/metastasis (except thymoma); 7. Those with active infection during screening (such as herpes zoster, positive HIV antibody, active tuberculosis, etc.); 8. Those currently have active hepatitis or have severe liver disease and history; 9. Diabetic patients with poor blood sugar control: HbAlc > 9.0% or FBG >= 11.1 mmol/L; 10. Those who received live vaccines within 3 months before screening, or plan to receive vaccines during the trial; 11. Those with thymic tumors, or had thymectomy within 6 months before screening, or plan to undergo thymectomy during the study; 12. Those allergic to human biological products; 13. Those who participated in any clinical trial within 28 days before randomization, or were within 5 half-lives (take the longer time) of any drug in the clinical trial; 14. Pregnant, lactating women, and men or women with fertility plans during the study; 15. Those with alcohol or drug abuse that affects the experimental conditions; 16. Researchers consider the candidate unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QMG; | — |
Secondary
| Measure | Time frame |
|---|---|
| MG relevant clinical score;Safety evaluation;Clinical parameters; | — |
Countries
China
Contacts
Public ContactSushan Luo
Huashan Hospital, Fudan University
Outcome results
None listed