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.
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.
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.
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 site. The study plans to enroll 19 patients.
Case-only
Prospective
Upadacitinib
DrugAs 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.
Changes in B-mode and Doppler-mode ultrasound enthesitis
Changes from baseline in B-mode and Doppler-mode enthesitis measured by the Outcome Meaures in Rheumatology (OMERACT) enthesitis scoring system (0, no to 3, severe, at each evaluated enthesis) at 24 weeks of follow-up.
Changes in B-mode and Doppler-mode ultrasound enthesitis
Changes in B-mode and Doppler-mode enthesitis measured by the OMERACT enthesitis scoring system at 12 weeks.
Change in Disease Activity in Psoriatic Arthritis (DAPSA) score
Change in DAPSA score between baseline to week 12 and baseline to week 24.
Change in Leeds Enthesitis Index (LEI) score (0-6)
Change in LEI score between baseline to week 12 and baseline to week 24.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Hospital Universitario de Móstoles
Collaborator
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