Behcet's disease, Idiopathic Inflammatory Myopathies
Conditions
Brief summary
EuroQol 5D-5L (EQ-5D-5L) form, Behçet’s Disease Current Activity Form (BDCAF), Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group
Detailed description
AUC for number of oral ulcers, Cutaneous Dermatomyositis Disease Area and Severity index (CDASI), Total number of flares in each disease, measured by a ≥1 point increase in Physician Global Assessment (PGA) on a scale from 0-3, Visual Analogue Scale (VAS) of disease activity, based on the clinical view of the local principal investigator, Glucocorticoid Toxicity Index (GTI), Changes in glucocorticoid dose, VAS score of pain, patients perspective, Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), Patient Acceptable Symptom State (PASS), Exposure-adjusted incidence rates for treatment-emergent adverse events
Interventions
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EuroQol 5D-5L (EQ-5D-5L) form, Behçet’s Disease Current Activity Form (BDCAF), Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC for number of oral ulcers, Cutaneous Dermatomyositis Disease Area and Severity index (CDASI), Total number of flares in each disease, measured by a ≥1 point increase in Physician Global Assessment (PGA) on a scale from 0-3, Visual Analogue Scale (VAS) of disease activity, based on the clinical view of the local principal investigator, Glucocorticoid Toxicity Index (GTI), Changes in glucocorticoid dose, VAS score of pain, patients perspective, Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), Patient Acceptable Symptom State (PASS), Exposure-adjusted incidence rates for treatment-emergent adverse events | — |
Countries
Netherlands
Outcome results
None listed