Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06144567
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06144567
Study Brief:
Protocol Section:
NCT06144567