Active Psoriatic Arthritis
Conditions
Brief summary
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20)
Detailed description
Change from baseline in DAS28-CRP score at Week 16, Change from baseline in HAQ-DI score at Week 16, Proportion of participants meeting PASI 75 response at Week 16, in participants with at least 3% BSA involvement AND at least sPGA 2 at baseline, Change from baseline in the SF-36 PCS score at Week 16, Proportion of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at baseline by LEI at Week 16, Proportion of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: a) Tender joint count ≤ 1 b) Swollen joint count ≤ 1 c) PASI ≤ 1 or BSA ≤ 3% d) Patient assessment of PsA pain ≤ 15 e) Patient Global Assessment of PsA disease activity ≤ 20 f) HAQ-DI ≤ 0.5 g) Tender enthesial points ≤ 1, Change from baseline in FACIT-Fatigue score at Week 16, Proportion of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in DAS28-CRP score at Week 16, Change from baseline in HAQ-DI score at Week 16, Proportion of participants meeting PASI 75 response at Week 16, in participants with at least 3% BSA involvement AND at least sPGA 2 at baseline, Change from baseline in the SF-36 PCS score at Week 16, Proportion of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at baseline by LEI at Week 16, Proportion of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: a) Tender joint count ≤ 1 b) Swollen joint count ≤ 1 c) PASI ≤ 1 or BSA ≤ 3% d) Patient assessment of PsA pain ≤ 15 e) Patient Global Assessment of PsA disease activity ≤ 20 f) HAQ-DI ≤ 0.5 g) Tender enthesial points ≤ 1, Change from baseline in FACIT-Fatigue score at Week 16, Proportion of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as | — |
Countries
Belgium, Czechia, Germany, Hungary, Poland, Spain