Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06144567 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Esperanza Naredo |
Principal Investigator Affiliation | Hospital Universitario Fundación Jiménez Díaz |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | Spain |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis |
Contact a Trial Team
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