Active Idiopathic Inflammatory Myopathy including dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy or Juvenile Idiopathic Inflammatory Myopathy
Conditions
Brief summary
Incidence and severity of AEs
Detailed description
Incidence and severity of AEs, including changes in laboratory values and vital signs, Levels of B cells in the blood, Levels of CABA-201-positive T cells in the blood, Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum, Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum, Total Improvement Score (0 to 100, with higher scores indicating greater improvement) based on the Core Set Measures
Interventions
DRUGFludarabin Accord 25 mg/ml Konzentrat zur Herstellung einer Injektions- /Infusionslösung
DRUGEndoxan Baxter 1 g Polvere per soluzione iniettabile
DRUGFludarabina Teva
DRUGconcentrato per soluzione iniettabile o per infusione
DRUGEndoxan
Sponsors
Cabaletta Bio Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs, including changes in laboratory values and vital signs, Levels of B cells in the blood, Levels of CABA-201-positive T cells in the blood, Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum, Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum, Total Improvement Score (0 to 100, with higher scores indicating greater improvement) based on the Core Set Measures | — |
Outcome results
None listed