An Observational Study to Assess Change in Disease Activity and Treatment Patterns of Upadacitinib When Given Alone or Co-Administered With Methotrexate in Adult Participants With Active Psoriatic Arthritis (UPtimum-PsA)

AbbVie

Status: Active, not recruiting

Conditions: Psoriatic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05616871

P22-897

Details and patient eligibility

About

Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis.

Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of active psoriatic arthritis (PsA) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician.
• Physician decision on participant 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.
• Participants able to understand and communicate with the investigator and comply with the requirements of the study.

Exclusion criteria

• Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
• Prior treatment with upadacitinib.

Trial design

450 participants in 1 patient group

Upadacitinib Alone or In Combination with Methotrexate

Description:

Participants will receive upadacitinib alone or in combination with methotrexate as prescribed by their physician according to local label in real- world practice.