Generalized myasthenia gravis
Conditions
Interventions
Ecuzumab treatment group:None
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Meet the diagnostic criteria for refractory myasthenia gravis and satisfy any one of the following: a. Poor response to conventional immunotherapy drugs; b. Cannot tolerate adverse drug reactions or have contraindications for use; c. The condition is prone to recurrence and requires regular remedial treatment, making it difficult to achieve the treatment goal. 3. In the acute exacerbation stage, that is, the myasthenia Gravis Daily Living Scale (MG-ADL) score increased by >=2 points within one week before enrollment; 4. Positive for anti-acetylcholine receptor (AChR) antibodies (detected by CBA or RIA methods); 5. Be able to understand the content of this research and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is an uncontrolled active infection. 2. Has not completed the Neisseria meningitidis vaccination and is unwilling or unable to receive preventive antibiotic treatment as prescribed by the doctor; 3. Pregnant or lactating women; 4. There are serious diseases of the heart, liver, kidneys, blood system or other systems, and the researchers consider them unsuitable to participate in the study. 5. Allergic to ecucizumab or its components; 6. The medical records are incomplete and cannot meet the needs of research evaluation. 7. Currently participating in other clinical studies that may affect the results or safety of this research; 8. The subject himself/herself does not have sufficient capacity for informed consent, and is unable to obtain written informed consent from his/her guardian/legal representative, or although the subject himself/herself was given consent by the guardian/legal representative on his/her behalf, he/she clearly expressed his/her refusal to participate in the study. 9. The researchers believe that there are other circumstances that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement ratio of MG-ADL score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Subjects with a > 3-Point Improvement from Baseline in MG-ADL Score;The rate of achieving clinical remission;Immunology and laboratory indicators;Clinical safety and occurrence of adverse reactions;Steroid-Sparing Effect; | — |
Countries
China
Contacts
Public ContactYong Zhang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed