Myasthenia gravis
Conditions
Interventions
Tocilizumab treatment group:Tocilizumab+Oral corticosteroids
Conventional immunotherapy group:Oral immunosuppressant
Sponsors
Department of Neurology, The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. At the research center, the neurologist was diagnosed with myasthenia gravis according to the diagnostic criteria of the 2015 Chinese Myasthenia Gravis Guidelines; 2. Aged >= 18 years; 3. MGFA classification IIa-IVa, acetylcholine receptor antibody (+); 4. Receiving traditional immunotherapy (hormone + tacrolimus or hormone alone) and the drug dose is stable for more than 1 month before the first evaluation of the group; or after the physician's evaluation, it is determined that the tocilizumab combined hormone therapy program will be accepted; 5. Agree to accept blood sample collection; 6. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complicated with other neurological diseases, which interferes with the assessment of MG status; 2. Combined with unresected thymoma; 3. Pregnant or lactating women; 4. Women of childbearing age who have family planning; 5. Severe anxiety, depression and schizophrenia; 6. Suffer from other serious systemic diseases, and the expected survival period is less than 6 months; 7. Patients considered by the researcher to be unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with symptom relief at study week 24 (MG-ADL improvement >= 2 points); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in QMG score from baseline at study week 12;Proportion of patients with symptom relief in the 12th week of the study (MG-ADL improvement >= 2 points);The proportion of patients whose hormones were reduced to less than 10 mg/d at week 12 of the study;The average daily dose of steroids at the 12th week of the study;The change in QoL-15 score from baseline at week 12 of the study;The change in QMG score from baseline at week 24 of the study;Proportion of patients with symptom relief in the 24th week of the study (MG-ADL improvement >= 2 points);The proportion of patients whose hormones were reduced to less than 10 mg/d at week 24 of the study;The average daily dose of steroids at week 24 of the study;The change in QoL-15 score from baseline at the 24th week of the study; | — |
Countries
China
Contacts
Public ContactChangTing
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed