Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study ID
NCT06144567
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2023
Status verified
Nov 2023
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
19 participants (estimated)

Arms

  • Arm: Adult patients with PsA according to CASPAR classification criteria
    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.

Primary Outcome Measure

Changes in B-mode and Doppler-mode ultrasound enthesitis [ Time Frame: Baseline to week 24 ]

Central Contacts

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