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
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT05616871
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- Prior treatment with upadacitinib.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 \[tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL\].
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536
🇫🇷Nice CEDEX 1, Alpes-Maritimes, France
CH Troyes - Hopital Simone Veil /ID# 252625
🇫🇷Troyes, Aube, France
CHU de Besancon - Jean Minjoz /ID# 252537
🇫🇷Besancon, Doubs, France
CHU Limoges - Dupuytren 1 /ID# 252432
🇫🇷Limoges CEDEX 1, Franche-Comte, France
CHU Toulouse - Hopital Purpan /ID# 252077
🇫🇷TOULOUSE Cedex 9, Haute-Garonne, France
CHU Montpellier - Hopital Saint Eloi /ID# 252078
🇫🇷Montpellier Cedex 5, Herault, France
CHU Grenoble - Hopital Michallon /ID# 252601
🇫🇷La Tronche, Isere, France
CHU Bordeaux - Hopital Pellegrin /ID# 252532
🇫🇷Bordeaux, Nouvelle-Aquitaine, France
Ch Beauvais /Id# 252464
🇫🇷Beauvais CEDEX, Oise, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
🇫🇷Creteil, Paris, France
Scroll for more (78 remaining)Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536🇫🇷Nice CEDEX 1, Alpes-Maritimes, France