Status:
NOT_YET_RECRUITING
Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborating Sponsors:
Hospital Universitario de Móstoles
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-65 years
Brief 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...
Detailed Description
Rationale and Background: Psoriatic arthritis (PsA) is a complex and heterogeneous skin-musculoskeletal disease with a broad clinical phenotype spectrum of mostly peripheral (i.e., arthritis, enthesi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06144567
Start Date
December 1 2023
End Date
June 1 2026
Last Update
November 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
Madrid, Spain, 28040