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Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

NCT06144567 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Upadacitinib

As 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.

Sponsors & Collaborators

  • Hospital Universitario de Móstoles

    collaborator OTHER

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Esperanza Naredo · Hospital Universitario Fundación Jiménez Díaz

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144567 on ClinicalTrials.gov