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
Infirmerie Protestante /ID# 252075
🇫🇷Caluire Et Cuire, Rhone, France
Cabinet libéral du Dr PAUPIERE /ID# 252604
🇫🇷Peronne, Somme, France
Centre Hospitalier d'Arras /ID# 252529
🇫🇷Arras, France
CH de Cannes - Simone Veil /ID# 252600
🇫🇷Cannes, France
CHRU Tours - Hopital Trousseau /ID# 252528
🇫🇷Chambray Les Tours, France
ELSAN - Clinique du Pont de Chaume /ID# 252602
🇫🇷Montauban, France
Krankenhaus der Barmherzigen Brüder Trier /ID# 254762
🇩🇪Trier, Rheinland-Pfalz, Germany
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
Ch Beauvais /Id# 252464
🇫🇷Beauvais CEDEX, Oise, France
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549
🇫🇷La Roche Sur Yon, Vendee, France
CH AIX LES BAIN - Reine Hortense /ID# 252465
🇫🇷Aix Les Bains, France
Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523
🇫🇷Antibes, France
Centre Hospitalier de Boulogne Sur Mer /ID# 252467
🇫🇷Boulogne sur Mer, France
Centre Hospitalier Jean Rougie /ID# 259550
🇫🇷Cahors, France
AP-HP - Hopital Saint-Antoine /ID# 252627
🇫🇷Paris, France
Hôpital Charles-Nicolle /ID# 252603
🇫🇷Rouen, France
Dr. Murawski /ID# 257911
🇩🇪Neunkirchen, Saarland, Germany
Aurich & Sieburg, Magdeburg /ID# 255504
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
MVZ Herzogin Elisabeth Hospital /ID# 266740
🇩🇪Brunswick, Germany
Universitaetsmedizin Greifswald /ID# 254756
🇩🇪Greifswald, Germany
RHIO Forschungsinstitut /ID# 254752
🇩🇪Meerbusch, Germany
Krankenhaus St. Josef /ID# 254755
🇩🇪Wuppertal, Germany
General Hospital of Athens Laiko /ID# 247634
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Laiko /ID# 258030
🇬🇷Athens, Attiki, Greece
General Hospital of Elefsina Thriassio /ID# 251900
🇬🇷Magoula (Attikis), Attiki, Greece
IRCCS Istituto Clinico Humanitas /ID# 251275
🇮🇹Rozzano, Lombardia, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 250819
🇮🇹Ancona, Italy
A.O.U. Consorziale Policlinico di Bari /ID# 251508
🇮🇹Bari, Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544
🇮🇹Udine, Italy
CHU Grenoble - Hopital Michallon /ID# 252601
🇫🇷La Tronche, Isere, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
🇫🇷Creteil, Paris, France
Chic Castres-Mazamet /Id# 259557
🇫🇷Castres CEDEX, Tarn, France
CH Henri Duffaut /ID# 252620
🇫🇷Avignon CEDEX 9, Vaucluse, France
Clinique de la Sauvegarde /ID# 252533
🇫🇷Lyon, France
CH de Narbonne /ID# 252525
🇫🇷Narbonne, France
GH Diaconesses Croix Saint-Simon /ID# 252463
🇫🇷Paris, France
Rheumazentrum Ruhrgebiet /ID# 252939
🇩🇪Herne, Nordrhein-Westfalen, Germany
Beyer, Kaiserslautern, DE /ID# 254754
🇩🇪Kaiserslautern, Rheinland-Pfalz, Germany
CHU Bordeaux - Hopital Pellegrin /ID# 252532
🇫🇷Bordeaux, Nouvelle-Aquitaine, France
C. H. Sud Francilien /ID# 254945
🇫🇷Corbeil Essonnes, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530
🇫🇷Orléans, France
CHU de Rennes - Hospital Sud /ID# 252478
🇫🇷Rennes CEDEX 2, France
Cabinet Du Dr Judith Payet Dubourg /Id# 252668
🇫🇷St Pierre, France
Rheumapraxis Dr. Prothmann /ID# 254759
🇩🇪Püttlingen, Saarland, Germany
Kupka & Kupka, Altenburg, DE /ID# 254758
🇩🇪Altenburg, Germany
Praxis Dr. Silke Zinke /ID# 258037
🇩🇪Berlin, Germany
251 Airforce General Hospital /ID# 248092
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Gennimatas /ID# 247635
🇬🇷Athens, Attiki, Greece
Iaso /ID# 247649
🇬🇷Maroussi, Attiki, Greece
Naval Hospital of Athens /ID# 247631
🇬🇷Athens, Greece
Iaso Thessalias S.A. /Id# 255110
🇬🇷Larisa, Greece
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183
🇮🇹Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669
🇮🇹Rome, Roma, Italy
CHU Amiens-Picardie Site Sud /ID# 252527
🇫🇷Amiens CEDEX 1, Somme, France
CH La Rochelle - Hopital Saint Louis /ID# 252534
🇫🇷La Rochelle, France
Hopital St Joseph - St Luc (Lyon) /ID# 259561
🇫🇷Lyon, France
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 252526
🇫🇷Paris, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 252531
🇫🇷Paris, France
MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115
🇩🇪Erfurt, Thueringen, Germany
Praxis Dilltal /ID# 254761
🇩🇪Ehringshausen, Germany
Henry Dunnant Hospital Center /ID# 247640
🇬🇷Athens, Attiki, Greece
University General Hospital of Ioannina /ID# 251899
🇬🇷Ioannina, Greece
Reg Gen Univ Hosp Larissa /ID# 247642
🇬🇷Larisa, Greece
Bioclinic Thessaloniki /ID# 247648
🇬🇷Thessaloniki, Greece
Euromedica Blue Cross Gen Clin /ID# 251898
🇬🇷Thessaloniki, Greece
Euromedica General Clinic /ID# 251897
🇬🇷Thessaloniki, Greece
Azienda Ospedaliera Universitaria Senese /ID# 251146
🇮🇹Siena, Italy
Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
🇩🇪Berlin, Germany
Dr. Bolze, Ludwigshafen, DE /ID# 254134
🇩🇪Ludwigshafen, Germany
Olympion General Clinic /ID# 247644
🇬🇷Patras, Achaia, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 247643
🇬🇷Thessaloniki, Greece
IRCCS Ospedale San Raffaele /ID# 251562
🇮🇹Milan, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817
🇮🇹Rome, Roma, Italy
Universita degli Studi del Molise /ID# 251176
🇮🇹Campobasso, Italy
Dr. Heintz /ID# 254757
🇩🇪Hamburg, Germany
Prof-med-stud.de /ID# 265965
🇩🇪Munich, Germany
Knappschaftsklinikum Saar /ID# 255505
🇩🇪Puettlingen, Germany
General Hospital of Athens Ippokratio /ID# 247633
🇬🇷Athens, Attiki, Greece
University General Hospital Attikon /ID# 248093
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 247632
🇬🇷Heraklion, Kriti, Greece
KAT Atttica General Hospital /ID# 247641
🇬🇷Athens, Greece
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789
🇮🇹Palermo, Italy
Fondazione IRCCS Policlinico San Matteo /ID# 250747
🇮🇹Pavia, Italy