Active Idiopathic Inflammatory Myopathy (IIM)
Conditions
Brief summary
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time, Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time
Detailed description
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) over time, Prednisone dose reduction (average monthly dose) over time, Total improvement score (TIS) over time, Proportion of TIS responders (minimal, moderate, major) over time, Individual core set measure (CSMs) of the TIS over time, Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter), Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time, Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) over time, Prednisone dose reduction (average monthly dose) over time, Total improvement score (TIS) over time, Proportion of TIS responders (minimal, moderate, major) over time, Individual core set measure (CSMs) of the TIS over time, Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter), Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study | — |
Countries
Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden