Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis (NCT06144567) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis
Spain19 participantsStarted 2023-12
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in B-mode and Doppler-mode ultrasound enthesitis
Timeframe: Baseline to week 24
Trial details
NCT IDNCT06144567
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz