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Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Summary
Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 24. Secondary objective: 1. To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 12. 2. To evaluate the clinical response of enthesitis to upadacitinib by LEI, at week 12 and week 24. 3. To evaluate the clinical response of disease activity by DAPSA, at week 12 and week 24. Study Design: single-arm, observational longitudinal, prospective study Population: The study population will consist of adult patients (aged ≥ 18 years old and ≤ 65 years old) with PsA according to CASPAR classification criteria, who have been prescribed upadacitinib over the course of routine practice, in accordance with the applicable approved label and local regulatory and reimbursement policies ("In patients with psoriatic arthritis, upadacitinib would be a therapeutic alternative after failure, inadequate response or intolerance to csDMARDs and anti-TNF") and have at least one ultrasound-determined peripheral enthesitis.
Official title: Ultrasound-based Response of Enthesitis to Upadacitinib in Psoriatic Arthritis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
19
Start Date
2023-12
Completion Date
2026-06
Last Updated
2023-11-29
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
As this is an observational study, AbbVie is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
Locations (1)
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
Madrid, Spain