dermatomyositis
Conditions
Interventions
Abatacept treatment group:The initial dose was 10 mg/kg per month, and the intravenous infusion treatment of the treatment group was started by OW for 3 months.
Saline group:Using a light-shielding simulation bag that was completely consistent with the appearance and measurement of Abatacept, intravenous infusion was started for the placebo group at 0W. The i
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. EULAR/ACR 2017 IIM inflammatory myopathy defines adult age> 18 years old and DM (the corresponding total score for patients with muscle tissue biopsy is >= 8.7, and the corresponding total score for patients without muscle tissue biopsy is >= 7.5) ; 2. CT clearly diagnosed ILD, and exclude infection, dust inhalation and other ILD with clear etiology; 3. Anti-MDA5 antibody positive; 4. FLAIR mortality risk scoring system 10-13 points ; 5. Aged 18-70 years; 6. Consent to contraception.
Exclusion criteria
Exclusion criteria: 1. With other autoimmune diseases, such as rheumatoid arthritis, Sjogrens syndrome, scleroderma, autoimmune liver disease, etc.; 2. Received the following treatment within 90 days before screening: (1) Anti-TNF-a, IL-6, IL-1, BAFF treatment, (2) Treatment with high-dose hormones (>100mg/d, calculated as prednisone), (3) Plasma exchange, blood adsorption, hemodialysis, mesenchymal stem cell transplantation, etc.; (4) Active infection during the screening period; 3. Active viral hepatitis; 4. Active tuberculosis; 5. Patients with abnormal liver function (ALT or AST exceeds 2 times the upper limit of normal); 6. Those who have a history of alcoholism within 2 years; 7. Those with a history of malignant tumors, except for cured, carcinoma in situ and basal cell carcinoma; 8. Patients with severe cardiopulmonary insufficiency and severe hypertension; 9. People with mental illness; 10. Epilepsy and other nervous system disorders; 11. Pregnant and lactating women patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HRCT score;KB-ILD score;NLR;pulmonary function forced vital capacity;pulmonary function Diffusing Capacity of the Lung for Carbon Monoxide;KL-6;1-year survival rate; | — |
Countries
China
Contacts
Public ContactGuo Qiang
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed