dermatomyositis
Conditions
Interventions
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Diagnosed with DM or CADM and anti-MDA5 antibody positive according to Bohan and Peter criteria or Sontheimer criteria; 3. The diagnosis of ILD is based on the criteria proposed by the American Thoracic Society and confirmed by HRCT, and the course of ILD is less than or equal to 3 months; 4. Impaired lung function but FVC >= 50% of the predicted value and DLCO accounts for >= 30% of the predicted value; 5. Those who have not used biological agents (including but not limited to rituximab, infliximab, adalimumab, etanercept, etc.) or have been discontinued for >=3 months during screening; 6. Agree to use effective contraception during the study period (women of childbearing age); 7. Voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other connective tissue diseases or tumors; 2. Patients with severe cardiovascular and cerebrovascular diseases; 3. Alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) >= 2 times the upper limit of normal reference value (ULN); 4. Serum creatinine>= ULN or glomerular filtration rate (eGFR)<60ml/min/1.73m^2; 5. Combined with serious opportunistic infections during screening; 6. Chest CT and/or Mycobacterium tuberculosis-specific cellular immune response test suggest that subjects may have tuberculosis infection; 7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-syphilis antibody (TP-Ab), meeting any of them; 8. Those who are known to be allergic or intolerant to this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month survival rate;Lung HRCT score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle strength score MMT8;Pulmonary function forced vital capacity; | — |
Countries
China
Contacts
Public ContactWu Jian
the First Affiliated Hospital of Soochow University
Outcome results
None listed