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

NCT ID: NCT05616871

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib Alone or In Combination with Methotrexate

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536

Nice, Alpes-Maritimes, France

Site Status

CH Troyes - Hopital Simone Veil /ID# 252625

Troyes, Aube, France

Site Status

CHU de Besancon - Jean Minjoz /ID# 252537

Besançon, Doubs, France

Site Status

CHU Limoges - Dupuytren 1 /ID# 252432

Limoges, Franche-Comte, France

Site Status

CHU Toulouse - Hopital Purpan /ID# 252077

Toulouse, Haute-Garonne, France

Site Status

CHU Montpellier - Hopital Saint Eloi /ID# 252078

Montpellier, Herault, France

Site Status

CHU Grenoble - Hopital Michallon /ID# 252601

La Tronche, Isere, France

Site Status

CHU Bordeaux - Hopital Pellegrin /ID# 252532

Bordeaux, Nouvelle-Aquitaine, France

Site Status

Ch Beauvais /Id# 252464

Beauvais, Oise, France

Site Status

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194

Créteil, Paris, France

Site Status

Infirmerie Protestante /ID# 252075

Caluire-et-Cuire, Rhone, France

Site Status

CHU Amiens-Picardie Site Sud /ID# 252527

Amiens, Somme, France

Site Status

Cabinet libéral du Dr PAUPIERE /ID# 252604

Péronne, Somme, France

Site Status

Chic Castres-Mazamet /Id# 259557

Castres, Tarn, France

Site Status

CH Henri Duffaut /ID# 252620

Avignon, Vaucluse, France

Site Status

CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549

La Roche-sur-Yon, Vendee, France

Site Status

CH AIX LES BAIN - Reine Hortense /ID# 252465

Aix-les-Bains, , France

Site Status

Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523

Antibes, , France

Site Status

Centre Hospitalier d'Arras /ID# 252529

Arras, , France

Site Status

Centre Hospitalier de Boulogne Sur Mer /ID# 252467

Boulogne-sur-Mer, , France

Site Status

Centre Hospitalier Jean Rougie /ID# 259550

Cahors, , France

Site Status

CH de Cannes - Simone Veil /ID# 252600

Cannes, , France

Site Status

CHRU Tours - Hopital Trousseau /ID# 252528

Chambray-lès-Tours, , France

Site Status

C. H. Sud Francilien /ID# 254945

Corbeil-Essonnes, , France

Site Status

CH La Rochelle - Hopital Saint Louis /ID# 252534

La Rochelle, , France

Site Status

Hopital St Joseph - St Luc (Lyon) /ID# 259561

Lyon, , France

Site Status

Clinique de la Sauvegarde /ID# 252533

Lyon, , France

Site Status

ELSAN - Clinique du Pont de Chaume /ID# 252602

Montauban, , France

Site Status

CH de Narbonne /ID# 252525

Narbonne, , France

Site Status

Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530

Orléans, , France

Site Status

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 252526

Paris, , France

Site Status

AP-HP - Hopital Saint-Antoine /ID# 252627

Paris, , France

Site Status

AP-HP - Hopital Bichat - Claude-Bernard /ID# 252531

Paris, , France

Site Status

GH Diaconesses Croix Saint-Simon /ID# 252463

Paris, , France

Site Status

CHU de Rennes - Hospital Sud /ID# 252478

Rennes, , France

Site Status

Hôpital Charles-Nicolle /ID# 252603

Rouen, , France

Site Status

Cabinet Du Dr Judith Payet Dubourg /Id# 252668

Saint-Pierre-des-Corps, , France

Site Status

Rheumazentrum Ruhrgebiet /ID# 252939

Herne, North Rhine-Westphalia, Germany

Site Status

Beyer, Kaiserslautern, DE /ID# 254754

Kaiserslautern, Rhineland-Palatinate, Germany

Site Status

Krankenhaus der Barmherzigen Brüder Trier /ID# 254762

Trier, Rhineland-Palatinate, Germany

Site Status

Dr. Murawski /ID# 257911

Neunkirchen, Saarland, Germany

Site Status

Rheumapraxis Dr. Prothmann /ID# 254759

Püttlingen, Saarland, Germany

Site Status

Aurich & Sieburg, Magdeburg /ID# 255504

Magdeburg, Saxony-Anhalt, Germany

Site Status

MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115

Erfurt, Thuringia, Germany

Site Status

Kupka & Kupka, Altenburg, DE /ID# 254758

Altenburg, , Germany

Site Status

Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152

Berlin, , Germany

Site Status

Praxis Dr. Silke Zinke /ID# 258037

Berlin, , Germany

Site Status

MVZ Herzogin Elisabeth Hospital /ID# 266740

Braunschweig, , Germany

Site Status

Praxis Dilltal /ID# 254761

Ehringshausen, , Germany

Site Status

Universitaetsmedizin Greifswald /ID# 254756

Greifswald, , Germany

Site Status

Dr. Heintz /ID# 254757

Hamburg, , Germany

Site Status

Dr. Bolze, Ludwigshafen, DE /ID# 254134

Ludwigshafen, , Germany

Site Status

RHIO Forschungsinstitut /ID# 254752

Meerbusch, , Germany

Site Status

Prof-med-stud.de /ID# 265965

Munich, , Germany

Site Status

Knappschaftsklinikum Saar /ID# 255505

Püttlingen, , Germany

Site Status

Krankenhaus St. Josef /ID# 254755

Wuppertal, , Germany

Site Status

Olympion General Clinic /ID# 247644

Pátrai, Achaia, Greece

Site Status

251 Airforce General Hospital /ID# 248092

Athens, Attica, Greece

Site Status

Henry Dunnant Hospital Center /ID# 247640

Athens, Attica, Greece

Site Status

General Hospital of Athens Gennimatas /ID# 247635

Athens, Attica, Greece

Site Status

General Hospital of Athens Ippokratio /ID# 247633

Athens, Attica, Greece

Site Status

General Hospital of Athens Laiko /ID# 247634

Athens, Attica, Greece

Site Status

General Hospital of Athens Laiko /ID# 258030

Athens, Attica, Greece

Site Status

University General Hospital Attikon /ID# 248093

Athens, Attica, Greece

Site Status

General Hospital of Elefsina Thriassio /ID# 251900

Magoula (Attikis), Attica, Greece

Site Status

Iaso /ID# 247649

Marousi, Attica, Greece

Site Status

University General Hospital of Heraklion PA.G.N.I /ID# 247632

Heraklion, Crete, Greece

Site Status

Naval Hospital of Athens /ID# 247631

Athens, , Greece

Site Status

KAT Atttica General Hospital /ID# 247641

Athens, , Greece

Site Status

University General Hospital of Ioannina /ID# 251899

Ioannina, , Greece

Site Status

Iaso Thessalias S.A. /Id# 255110

Larissa, , Greece

Site Status

Reg Gen Univ Hosp Larissa /ID# 247642

Larissa, , Greece

Site Status

Bioclinic Thessaloniki /ID# 247648

Thessaloniki, , Greece

Site Status

Euromedica Blue Cross Gen Clin /ID# 251898

Thessaloniki, , Greece

Site Status

General Hospital of Thessaloniki Hippokrateio /ID# 247643

Thessaloniki, , Greece

Site Status

Euromedica General Clinic /ID# 251897

Thessaloniki, , Greece

Site Status

IRCCS Istituto Clinico Humanitas /ID# 251275

Rozzano, Lombardy, Italy

Site Status

IRCCS Ospedale San Raffaele /ID# 251562

Milan, Milano, Italy

Site Status

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183

Naples, Napoli, Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817

Rome, Roma, Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669

Rome, Roma, Italy

Site Status

Azienda Ospedaliero Universitaria delle Marche /ID# 250819

Ancona, , Italy

Site Status

A.O.U. Consorziale Policlinico di Bari /ID# 251508

Bari, , Italy

Site Status

Universita degli Studi del Molise /ID# 251176

Campobasso, , Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789

Palermo, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo /ID# 250747

Pavia, , Italy

Site Status

Azienda Ospedaliera Universitaria Senese /ID# 251146

Siena, , Italy

Site Status

Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544

Udine, , Italy

Site Status

Countries

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France Germany Greece Italy

Related Links

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Other Identifiers

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P22-897

Identifier Type: -

Identifier Source: org_study_id

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