Myasthenia gravis (MG)
Conditions
Interventions
Efgartigimod a Group:Patients in the igamuratid a group were intravenously infused with igamuratid a at a dose of 10mg/kg/d once a week for 4 consecutive weeks, and then supplemented with an appearanc
Intravenous gamma globulin group:Patients in the gamma globulin injection group were infused with gamma globulin at a dose of 0.4g/kg/d after enrollment for 5 consecutive days, followed by a placebo o
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 to 80 years old; 2. Meet the diagnostic criteria for generalized myasthenia gravis and be positive for acetylcholine receptor antibodies; 3. Clinical Classification of Myasthenia Gravis Foundation (MGFA) types II-IV; 4. For patients with deteriorated symptoms of muscle weakness before enrollment, it was manifested as ?MG-ADL from non-ocular muscles >=2 points and ?MG-QMG from non-ocular muscles >=3 points within 4 weeks; 5. Background: Requirements for the conventional treatment plan: a. For patients using bromopidemine tablets alone: The dose of bromopidemine tablets should be less than or equal to 360mg/d. For non-new patients, the dose should be stable for at least 2 weeks before enrollment. b. Patients using hormones alone: The hormone dose should be less than or equal to 60mg/d. For non-new patients, the dose should be stable for at least one month before enrollment. c. Patients with hormones combined with other immunosuppressants: The hormone dose should be less than or equal to 60mg/d. For non-new patients, the dose should remain stable for at least one month before enrollment. Meanwhile, the dose of other immunosuppressants such as tacrolimus and mycophenolate mofetil should remain stable for three months before the start of the study and during the study period. 6. The subjects were able and willing to sign the informed consent form before participating in this study.
Exclusion criteria
Exclusion criteria: 1.Within 1.2 months, intravenous immunoglobulin (IVIg) or plasma exchange (PE) was received; 2. Received igamtimod a treatment within 2 months or received telitacicept/ecucuzumab treatment within 3 months; 3. Having participated in any clinical trial within 28 days prior to the study or within five times the half-life of the investigational drug participating in the clinical trial; Within 4.6 months, the patient has received treatment with biological agents other than the above-mentioned ones, such as biological agents targeting CD19 and CD20. 5. Those with severe cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases, or those suffering from acute or chronic infections that require treatment, Specifically as follows: Being receiving any anti-infective treatment (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster or atypical mycobacteria) within 4 weeks before baseline; being admitted to hospital for anti-infective treatment within 60 days before baseline; having an infection requiring intravenous antibiotic (antibacterial, antiviral, antifungal or antiparasitic) treatment within 60 days before baseline; 6. Patients with other malignant tumors except thymoma (excluded within 6 months after thymoma surgery); 7. Patients with other serious autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, etc. 8. Women who are pregnant or breastfeeding and patients who have plans to have children during the trial period; 9. Allergy to human biological products; 10. Patients currently in the acute infection stage who require intravenous antibiotics; 11. Those with immunoglobulin IgG less than 400mg/L; 12. Any other circumstances where the researcher deems it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of MG-ADL score from baseline on the 14th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| ;The changes of MG-ADL scores from baseline on days 7, 21 and 28;The proportion of patients with MSE targets between the two groups on the 28th day;The proportion of patients who need to be admitted to the intensive care unit (ICU) or receive positive pressure ventilation, tracheal intubation or tracheotomy during the observation period;Cost-effectiveness analysis of medication in two groups; | — |
Countries
China
Contacts
Public ContactLi Jia;Zhang Xu
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed