PSORIATIC ARTHRITIS
Conditions
Brief summary
The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12].
Detailed description
The secondary endpoints are: - Patient-level ultrasonographic response according to multi-joint PsASon22 US score (56), measured as 20% variation in the inflammatory subscore [Time point: T12]; - Joint level ultrasonographic response according to single-joint PsASon22 US score (56) [Time point: T12]; - Other key clinical endpoints (ACR50, ACR70, DAPSA, MDA, HAQ-DI score; PGA, pain, PhGA, number of swollen/tender joints, BSA) [Time points: T12, T24]; - Response to treatment according to ACR20 res
Interventions
Sponsors
University Hospital Of Ferrara
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (59). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - Patient-level ultrasonographic response according to multi-joint PsASon22 US score (56), measured as 20% variation in the inflammatory subscore [Time point: T12]; - Joint level ultrasonographic response according to single-joint PsASon22 US score (56) [Time point: T12]; - Other key clinical endpoints (ACR50, ACR70, DAPSA, MDA, HAQ-DI score; PGA, pain, PhGA, number of swollen/tender joints, BSA) [Time points: T12, T24]; - Response to treatment according to ACR20 res | — |
Countries
Italy
Outcome results
None listed