Psoriatic Arthritis
Conditions
Brief summary
Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Changes in vital signs and clinical laboratory parameters.
Detailed description
American College of Rheumatology (ACR)20 response: Assessed as proportion of subjects achieving ACR20 at Weeks 24, 48, and 104., ACR50 response: Assessed as proportion of subjects achieving ACR50 at Weeks 24, 48, and 104., ACR70 response: Assessed as proportion of subjects achieving ACR70 at Weeks 24, 48, and 104., Minimal disease activity (MDA): Assessed as proportion of subjects achieving MDA status at Weeks 24, 48, and 104., Psoriasis Area and Severity Index (PASI)75 (in subjects with a baseline ≥3% body surface area): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Weeks 24, 48, and 104.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Changes in vital signs and clinical laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology (ACR)20 response: Assessed as proportion of subjects achieving ACR20 at Weeks 24, 48, and 104., ACR50 response: Assessed as proportion of subjects achieving ACR50 at Weeks 24, 48, and 104., ACR70 response: Assessed as proportion of subjects achieving ACR70 at Weeks 24, 48, and 104., Minimal disease activity (MDA): Assessed as proportion of subjects achieving MDA status at Weeks 24, 48, and 104., Psoriasis Area and Severity Index (PASI)75 (in subjects with a baseline ≥3% body surface area): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Weeks 24, 48, and 104. | — |