Ultrasound-based Response of Enthesitis to Upadacitinib in Psoriatic Arthritis

A24- 391

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.

2023-12-01

2026-06-01

2026-06-01

Not yet recruiting

19

Inclusion Criteria: * Adult male or female, at least ≥ 18 years old and ≤ 65 years old at Screening. * Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening visit and fulfillment of the Classification Criteria for PsA (CASPAR) (19). * Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies. * Inadequate response or intolerance to at least one bDMARD, one of them must be an anti-TNF according to the Spanish regulatory and reimbursement policies ("informe de posicionamiento terapéutico"). * Patients should have at least one ultrasound-determined peripheral enthesitis site according to OMERACT definition for ultrasound enthesitis. * Subjects must voluntarily sign and date an informed consent. Exclusion Criteria: * Patients who cannot be treated with upadacitinib according to the approved label (e.g., contraindications). * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive upadacitinib. * Unwillingness or inability to comply with the study requirements. * Prior exposure to any Janus kinase (JAK) inhibitor. * Patients taking ≥ 10 mg of prednisone or equivalent

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 19, 'type': 'ESTIMATED'}}

2023-11-29