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

NCT06144567 | Not Yet Recruiting FDA Drug

• 1 other identifier: A24- 391
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS, in PsA patients at week 12.
2. 2.To evaluate the clinical response of enthesitis to upadacitinib by LEI, at week 12 and week 24.
3. 3.To evaluate the clinical response of disease activity by DAPSA, at week 12 and week 24.

Conditions

Psoriatic Arthritis

Keywords

Ultrasound; Entheses; Psoriatic arthritis; Upadacitinib

Outcome Measures

Primary Outcomes (1)

• Changes in B-mode and Doppler-mode ultrasound enthesitis

  Changes from baseline in B-mode and Doppler-mode enthesitis measured by the Outcome Meaures in Rheumatology (OMERACT) enthesitis scoring system (0, no to 3, severe, at each evaluated enthesis) at 24 weeks of follow-up.

  Baseline to week 24

Secondary Outcomes (3)

• Changes in B-mode and Doppler-mode ultrasound enthesitis

  Baseline to week12

• Change in Disease Activity in Psoriatic Arthritis (DAPSA) score

  Baseline to week 12 ans 24

• Change in Leeds Enthesitis Index (LEI) score (0-6)

  Baeline to week 12 ans 24

Study Arms (1)

Adult patients with PsA according to CASPAR classification criteria

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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.

Also known as: Rinvoq

Adult patients with PsA according to CASPAR classification criteria

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 site. The study plans to enroll 19 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Hospital Universitario de Móstoles: collaborator

Study Sites (1)

Instituto de Investigación Sanitaria Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Esperanza Naredo

  Hospital Universitario Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia LLanos

CONTACT

+ 34 91 5504800; lucia.llanos@fjd.es

Mireia Arcas

CONTACT

+ 34 91 5504800; mireia.arcas@fjd.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)