idiopathic inflammatory myopathy
Conditions
Interventions
Test group:All patients with idiopathic inflammatory myopathy who meet the inclusion criteria will receive subcutaneous injection of 240 mg of tacrolizumab once a week for a total of 12 times from 0 t
Sponsors
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signs the informed consent form; 2. Age range is 14-70 years old, with no gender restrictions; 3. Patients diagnosed with idiopathic inflammatory myopathy according to the 2017 ACR/EULAR criteria; 4. Patients must be able to understand and comply with the relevant aspects of the research protocol, and must sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Active infection patients, such as herpes zoster HIV Active tuberculosis and active hepatitis; 2. Other malignant tumor patients; 3. Patients with severe liver and kidney dysfunction; 4. Used other targeted therapies with biological agents such as rituximab within the first 6 months of enrollment; 5. Use intravenous immunoglobulin or plasma exchange therapy within 2 months before enrollment; 6. Received any live vaccine within the 3 months prior to the study or planned to receive any vaccine during the study period; 7. Pregnant or lactating women and patients with fertility plans during the trial period 8. Allergic to human derived biological products; 9. Participated in any clinical trial within 28 days prior to the study or within 5 times the half-life of the investigational drug (whichever is longer) 10. Other researchers have determined that patients with severe mental disorders are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TIS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician Global Assessment (PhGA); Patient Global Assessment (PtGA); Health Assessment Questionnaire (HAQ); Muscle Disease Activity Assessment Tool (MDAAT);MMT-8 muscle strength score;Creatine kinase;Hormone prednisone dose; | — |
Countries
China
Contacts
Public ContactShao Yuquan
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed