Myasthenia gravis in adults
Conditions
Interventions
Twest group:In the first stage, the dose of agamod was 10 mg/kg intravenous infusion for 1 hour, once a week for 4 weeks.
Weekly subcutaneous injection of 240 mg of tatanercept was started after compl
Sponsors
Department of Neurology, Affiliated Hospital of Zunyi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion in this study: 1.Signed informed consent; 2.Male or female = 18 years old and = 80 years old at the screening visit; 3.Subjects with a diagnosis of generalized myasthenia gravis with documented confirmed diagnosis of MG prior to screening, as determined by clinical disease characteristics and at least one of the following confirmatory examinations. Unless otherwise noted, test results that may be collected from the subject's current records or obtained during the screening period: (1) a positive AChE inhibition test (e.g., onphenolkonium chloride test, tenxerone test, or neostigmine test); (2) Abnormal neuromuscular signaling confirmed by repetitive nerve stimulation or single-fiber electromyography; (3) Improvement in MG-related symptoms or signs confirmed by the attending physician after previous treatment with oral AChE inhibitors; 4.At screening, serum AchR-Ab or MUSK-Ab is positive; (5) Subjects (including females and males) agree to use effective contraceptive measures for contraception from the time of signing the informed consent form until 1 year after the last use of the study drug. Females of childbearing potential in the opinion of the investigator with a negative serum pregnancy test result prior to initiation of dosing.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be eligible for this study: 1. Presence or history of the following diseases: (1) History of malignancy, including myeloproliferative disorders or lymphoproliferative disorders. Unless considered cured by adequate treatment and no evidence of recurrence within =5 years prior to screening. Exceptions that do not need to be excluded from the study include treated skin cancer (other than malignant melanoma) and carcinoma in situ of the cervix; (2) Subjects with positive immunological examination for Mycobacterium tuberculosis can be enrolled if the subject meets the following conditions at the same time: (1) no imaging evidence suggestive of active tuberculosis; (2) Those without symptoms of tuberculosis poisoning (low-grade fever, fatigue, night sweats, loss of appetite, weight loss, etc.), or respiratory symptoms (cough, sputum for more than 2 weeks, or with hemoptysis, blood in sputum); (3) agree to receive prophylactic anti-tuberculosis therapy (e.g.: isoniazid 0.3g qd prophylaxis for 6 months); (3) Have autoimmune diseases other than MG, which will affect the judgment of clinical symptoms of myasthenia gravis as assessed by the investigator, including but not limited to: such as uncontrolled thyroid disease, severe rheumatoid arthritis, etc.; (4) Any untreated thymic malignancy, carcinoma or thymoma. (Thymomas classified as stage = II according to the Masaoka staging system are considered benign; Thymomas classified as stage = III are considered malignant); 1) Subjects with a history of thymic malignancy or cancer treatment are eligible to participate in the study if they meet all of the following criteria: 2) Treatment completion more than 5 years before screening. 3) No recurrence within 5 years prior to screening. 4) Computed tomography (CT) or magnetic resonance imaging (MRI) scans (including IV contrast agents) performed within 6 months prior to randomization showed no indication for radiological recurrence. 5) Subjects with a history of treatment for benign thymoma are eligible to participate in the study if they meet all of the following criteria: 6) Confirmation of benign thymoma diagnosis by histopathology or equivalent documentation. 7) Completion of treatment > 12 months prior to the screening visit. 8) No known recurrence within 12 months prior to the screening visit. 9) CT or MRI scans (including IV contrast media) performed within 6 months prior to randomization on Day 1 showed no indication for imaging recurrence. 10) If there is insufficient documentation to confirm a diagnosis of benign thymoma, subjects must meet the above eligibility criteria regarding thymic malignancy or carcinoma. 2. Active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding fungal infections in nail beds) requiring systemic antibiotics or antiviral therapy; 3. Positive for Hepatitis B Virus Surface Antigen (HBsAg) and HBV-DNA outside the normal range at screening, or positive for Hepatitis B Virus Core Antibody (HBcAb) and HBV DNA outside the normal range; 4. Positive for hepatitis C virus (HCV) antibody; Those with a history of immunodeficiency, including positive human immunodeficiency virus (HIV) antibodies, or other acquired and congenital immunodeficiency diseases; 5. Severe cardiovascular, hepatic, renal, respiratory, endocrine, or hematologic diseases, or other diseases that, in the opinion of the investigators, the subject cannot participate in the stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MG-ADL clinical absolute score;MG-QMG clinical absolute score;Change from baseline in MG-ADL score at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological examination: HBV-DNA quantitative;Tuberculosis test IGRAs (QFT-G or T-SPOT.TB);Thyroid function tests: 5 thyroid function tests (T3, T4, FT3, FT4, TSH);Complete blood count red blood cells, hemoglobin, white blood cells, neutrophils, eosinophils, basophils, lymphocytes, platelets;Blood biochemistry Urea nitrogen/urea, creatinine, alkaline phosphatase, uric acid, total protein, albumin, total bilirubin, direct bilirubin, ALT, AST, blood glucose, lactate dehydrogenase, electrolytes (K, Na, Ca, Mg, P, Cl), creatine kinase;Pregnancy test :HCG (test for women of childbearing age);Autoantibodies: AchR-Ab, MuSK-Ab;Immunological indicators: immunoglobulin (IgG, IgA, IgM), CD19 B cell count; | — |
Countries
China
Contacts
Public ContactZucai Xu
Affiliated Hospital of Zunyi Medical University
Outcome results
None listed