myasthenia gravis
Conditions
Interventions
Telitacicept:Telitacicept
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1,18-75 years old 2,Patients diagnosed with MG and positive for AchR Ab. The diagnostic criteria for MG are: based on typical clinical features of MG (fluctuating myasthenia), meeting any of the following three points, including pharmacological examination, electrophysiological examination, and MG serological antibody detection; 3,MGFA ?~IVa 4,MG-ADL= 5 ,>50% is not caused by ocular symptoms 5,Patients with stable standard treatment plans 6, signs an informed consent form
Exclusion criteria
Exclusion criteria: 1) Merge with other autoimmune diseases, such as SLE, rheumatoid arthritis, Sjogren's syndrome, etc; 2) Active infection patients, such as herpes zoster, HIV, active pulmonary tuberculosis, and active hepatitis; 3) Patients with concomitant thymic tumors or after thymectomy within the past 6 months; 4) Other malignant tumor patients; 5) Patients with severe liver and kidney dysfunction; 6) Within 6 months prior to enrollment, other biological targeted therapies such as rituximab were used; 7) Intravenous immunoglobulin injection or plasma exchange therapy within 2 months prior to enrollment; 8) Received any live vaccine within the first 3 months of the study or planned to receive any vaccine during the study period; 9) Pregnant or lactating women and patients with fertility plans during the trial period 10) Allergies to human derived biological products; 11) Has participated in any clinical trial 28 days prior to the study or within 5 times the half-life of the study drug participating in the clinical trial (whichever is longer) 12) Other researchers have determined that patients are not suitable for inclusion (such as severe mental disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in QMG score and MG-ADL score from baseline in the 24th week;changes in immunological indexes and lymphocyte count from baseline;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved minimal clinical manifestations (MMS) at week 24;Changes in AchR antibody titer levels before and after treatment;change from baseline in total hormonal use and other immunosuppressant use at week 24;Changes in immune cell subsets and immunological indexes before and after treatment;; | — |
Countries
china
Contacts
Public ContactYang Huan
Xiangya Hospital of Central South University
Outcome results
None listed