Severe refractory idiopathic inflammatory myopathies (IIM)
Conditions
Brief summary
Achieving moderate to major improvement in TIS (TIS ≥ 40) at Week 52 (Yes/No)
Detailed description
Achieving moderate to major improvement in TIS (≥ 40) at Week 52 (Yes/No), as defined for primary endpoint, Adjusted annual cumulative GC dose up to Week 52, Change from baseline in percent predicted Forced Vital Capacity (FVC%) at Week 52, Achieving major improvement in TIS (≥ 60) at Week 52 (Yes/No), as defined for primary endpoint but with a higher improvement required, Change from baseline in Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue 7a at Week 52, Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation
Interventions
DRUGTOCILIZUMAB
DRUGCYCLOPHOSPHAMIDE
DRUGRITUXIMAB
DRUGMYCOPHENOLATE MOFETIL
DRUGFLUDARABINE PHOSPHATE
DRUGMYCOPHENOLIC ACID
DRUGYTB323
DRUGTACROLIMUS
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieving moderate to major improvement in TIS (TIS ≥ 40) at Week 52 (Yes/No) | — |
Secondary
| Measure | Time frame |
|---|---|
| Achieving moderate to major improvement in TIS (≥ 40) at Week 52 (Yes/No), as defined for primary endpoint, Adjusted annual cumulative GC dose up to Week 52, Change from baseline in percent predicted Forced Vital Capacity (FVC%) at Week 52, Achieving major improvement in TIS (≥ 60) at Week 52 (Yes/No), as defined for primary endpoint but with a higher improvement required, Change from baseline in Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue 7a at Week 52, Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed