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

Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05616871

Acronym

UPtimum-PsA

Enrollment

464

Registered

2022-11-15

Start date

2022-12-15

Completion date

2026-06-11

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis, PsA, UPA, Upadacitinib, Rinvoq®

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14	Month 6	Disease Activity in Psoriatic Arthritis (DAPSA) score is calculated by the sum of values of rheumatic parameters \[tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL\].

Countries

France, Germany, Greece, Italy

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results