Clinical trial NCT05616871: 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
Official title: Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
UPA
Upadacitinib
Rinvoq®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Psoriatic Arthritis (PsA)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Nice CEDEX 1
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536
state: Alpes-Maritimes
city: Troyes
country: France
facility: CH Troyes - Hopital Simone Veil /ID# 252625
state: Aube
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 252537
state: Doubs
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 252432
state: Franche-Comte
city: TOULOUSE Cedex 9
country: France
facility: CHU Toulouse - Hopital Purpan /ID# 252077
state: Haute-Garonne
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 252078
state: Herault
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 252601
state: Isere
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 252532
state: Nouvelle-Aquitaine
city: Beauvais CEDEX
country: France
facility: Ch Beauvais /Id# 252464
state: Oise
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
state: Paris
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante /ID# 252075
state: Rhone
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 252527
state: Somme
city: Peronne
country: France
facility: Cabinet libéral du Dr PAUPIERE /ID# 252604
state: Somme
city: Castres CEDEX
country: France
facility: Chic Castres-Mazamet /Id# 259557
state: Tarn
city: Avignon CEDEX 9
country: France
facility: CH Henri Duffaut /ID# 252620
state: Vaucluse
city: La Roche Sur Yon
country: France
facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549
state: Vendee
city: Aix Les Bains
country: France
facility: CH AIX LES BAIN - Reine Hortense /ID# 252465
city: Antibes
country: France
facility: Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523
city: Arras
country: France
facility: Centre Hospitalier d'Arras /ID# 252529
city: Boulogne sur Mer
country: France
facility: Centre Hospitalier de Boulogne Sur Mer /ID# 252467
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougie /ID# 259550
city: Cannes
country: France
facility: CH de Cannes - Simone Veil /ID# 252600
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 252528
city: Corbeil Essonnes
country: France
facility: C. H. Sud Francilien /ID# 254945
city: La Rochelle
country: France
facility: CH La Rochelle - Hopital Saint Louis /ID# 252534
city: Lyon
country: France
facility: Hopital St Joseph - St Luc (Lyon) /ID# 259561
city: Lyon
country: France
facility: Clinique de la Sauvegarde /ID# 252533
city: Montauban
country: France
facility: ELSAN - Clinique du Pont de Chaume /ID# 252602
city: Narbonne
country: France
facility: CH de Narbonne /ID# 252525
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530
city: Paris
country: France
facility: AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 252526
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 252627
city: Paris
country: France
facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 252531
city: Paris
country: France
facility: GH Diaconesses Croix Saint-Simon /ID# 252463
city: Rennes CEDEX 2
country: France
facility: CHU de Rennes - Hospital Sud /ID# 252478
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 252603
city: St Pierre
country: France
facility: Cabinet Du Dr Judith Payet Dubourg /Id# 252668
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 252939
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: Beyer, Kaiserslautern, DE /ID# 254754
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier /ID# 254762
state: Rheinland-Pfalz
city: Neunkirchen
country: Germany
facility: Dr. Murawski /ID# 257911
state: Saarland
city: Püttlingen
country: Germany
facility: Rheumapraxis Dr. Prothmann /ID# 254759
state: Saarland
city: Magdeburg
country: Germany
facility: Aurich & Sieburg, Magdeburg /ID# 255504
state: Sachsen-Anhalt
city: Erfurt
country: Germany
facility: MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115
state: Thueringen
city: Altenburg
country: Germany
facility: Kupka & Kupka, Altenburg, DE /ID# 254758
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke /ID# 258037
city: Brunswick
country: Germany
facility: MVZ Herzogin Elisabeth Hospital /ID# 266740
city: Ehringshausen
country: Germany
facility: Praxis Dilltal /ID# 254761
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald /ID# 254756
city: Hamburg
country: Germany
facility: Dr. Heintz /ID# 254757
city: Ludwigshafen
country: Germany
facility: Dr. Bolze, Ludwigshafen, DE /ID# 254134
city: Meerbusch
country: Germany
facility: RHIO Forschungsinstitut /ID# 254752
city: Munich
country: Germany
facility: Prof-med-stud.de /ID# 265965
city: Puettlingen
country: Germany
facility: Knappschaftsklinikum Saar /ID# 255505
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef /ID# 254755
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 247644
state: Achaia
city: Athens
country: Greece
facility: 251 Airforce General Hospital /ID# 248092
state: Attiki
city: Athens
country: Greece
facility: Henry Dunnant Hospital Center /ID# 247640
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Gennimatas /ID# 247635
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 247633
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 247634
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 258030
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 248093
state: Attiki
city: Magoula (Attikis)
country: Greece
facility: General Hospital of Elefsina Thriassio /ID# 251900
state: Attiki
city: Maroussi
country: Greece
facility: Iaso /ID# 247649
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 247632
state: Kriti
city: Athens
country: Greece
facility: Naval Hospital of Athens /ID# 247631
city: Athens
country: Greece
facility: KAT Atttica General Hospital /ID# 247641
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 251899
city: Larisa
country: Greece
facility: Iaso Thessalias S.A. /Id# 255110
city: Larisa
country: Greece
facility: Reg Gen Univ Hosp Larissa /ID# 247642
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki /ID# 247648
city: Thessaloniki
country: Greece
facility: Euromedica Blue Cross Gen Clin /ID# 251898
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 247643
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic /ID# 251897
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 251275
state: Lombardia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 251562
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183
state: Napoli
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817
state: Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 250819
city: Bari
country: Italy
facility: A.O.U. Consorziale Policlinico di Bari /ID# 251508
city: Campobasso
country: Italy
facility: Universita degli Studi del Molise /ID# 251176
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo /ID# 250747
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese /ID# 251146
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: