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

NCT05616871 | Active Not Recruiting

• 1 other identifier: P22-897
• Study Type: observational
• Target: 450
• Locations: 4 countries
• Sites: 88

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; PsA; UPA; Upadacitinib; Rinvoq®

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14

  Disease Activity in Psoriatic Arthritis (DAPSA) score is calculated by the sum of values of rheumatic parameters \[tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL\].

  Month 6

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Psoriatic Arthritis (PsA)

You may qualify if:

• 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.

You may not qualify if:

• Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
• Prior treatment with upadacitinib.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (88)

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

Nice, Alpes-Maritimes, 06001, France

Location

CH Troyes - Hopital Simone Veil /ID# 252625

Troyes, Aube, 10000, France

Location

CHU de Besancon - Jean Minjoz /ID# 252537

Besançon, Doubs, 25030, France

Location

CHU Limoges - Dupuytren 1 /ID# 252432

Limoges, Franche-Comte, 87042, France

Location

CHU Toulouse - Hopital Purpan /ID# 252077

Toulouse, Haute-Garonne, 31059, France

Location

CHU Montpellier - Hopital Saint Eloi /ID# 252078

Montpellier, Herault, 34295, France

Location

CHU Grenoble - Hopital Michallon /ID# 252601

La Tronche, Isere, 38700, France

Location

CHU Bordeaux - Hopital Pellegrin /ID# 252532

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Ch Beauvais /Id# 252464

Beauvais, Oise, 60021, France

Location

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

Créteil, Paris, 94010, France

Location

Infirmerie Protestante /ID# 252075

Caluire-et-Cuire, Rhone, 69300, France

Location

CHU Amiens-Picardie Site Sud /ID# 252527

Amiens, Somme, 80054, France

Location

Cabinet libéral du Dr PAUPIERE /ID# 252604

Péronne, Somme, 80200, France

Location

Chic Castres-Mazamet /Id# 259557

Castres, Tarn, 81108, France

Location

CH Henri Duffaut /ID# 252620

Avignon, Vaucluse, 84902, France

Location

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

La Roche-sur-Yon, Vendee, 85000, France

Location

CH AIX LES BAIN - Reine Hortense /ID# 252465

Aix-les-Bains, 73100, France

Location

Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523

Antibes, 06000, France

Location

Centre Hospitalier d'Arras /ID# 252529

Arras, 62022, France

Location

Centre Hospitalier de Boulogne Sur Mer /ID# 252467

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier Jean Rougie /ID# 259550

Cahors, 46005, France

Location

CH de Cannes - Simone Veil /ID# 252600

Cannes, 06400, France

Location

CHRU Tours - Hopital Trousseau /ID# 252528

Chambray-lès-Tours, 37170, France

Location

C. H. Sud Francilien /ID# 254945

Corbeil-Essonnes, 91106, France

Location

CH La Rochelle - Hopital Saint Louis /ID# 252534

La Rochelle, 17019, France

Location

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

Lyon, 69007, France

Location

Clinique de la Sauvegarde /ID# 252533

Lyon, 69009, France

Location

ELSAN - Clinique du Pont de Chaume /ID# 252602

Montauban, 82000, France

Location

CH de Narbonne /ID# 252525

Narbonne, 11100, France

Location

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

Orléans, 45067, France

Location

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

Paris, 75010, France

Location

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

Paris, 75012, France

Location

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

Paris, 75018, France

Location

GH Diaconesses Croix Saint-Simon /ID# 252463

Paris, 75020, France

Location

CHU de Rennes - Hospital Sud /ID# 252478

Rennes, 35203, France

Location

Hôpital Charles-Nicolle /ID# 252603

Rouen, 76000, France

Location

Cabinet Du Dr Judith Payet Dubourg /Id# 252668

Saint-Pierre-des-Corps, 97410, France

Location

Rheumazentrum Ruhrgebiet /ID# 252939

Herne, North Rhine-Westphalia, 44649, Germany

Location

Beyer, Kaiserslautern, DE /ID# 254754

Kaiserslautern, Rhineland-Palatinate, 67659, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier /ID# 254762

Trier, Rhineland-Palatinate, 54292, Germany

Location

Dr. Murawski /ID# 257911

Neunkirchen, Saarland, 66538, Germany

Location

Rheumapraxis Dr. Prothmann /ID# 254759

Püttlingen, Saarland, 66346, Germany

Location

Aurich & Sieburg, Magdeburg /ID# 255504

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115

Erfurt, Thuringia, 99096, Germany

Location

Kupka & Kupka, Altenburg, DE /ID# 254758

Altenburg, 04600, Germany

Location

Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152

Berlin, 12161, Germany

Location

Praxis Dr. Silke Zinke /ID# 258037

Berlin, 13055, Germany

Location

MVZ Herzogin Elisabeth Hospital /ID# 266740

Braunschweig, 38114, Germany

Location

Praxis Dilltal /ID# 254761

Ehringshausen, 35630, Germany

Location

Universitaetsmedizin Greifswald /ID# 254756

Greifswald, 17475, Germany

Location

Dr. Heintz /ID# 254757

Hamburg, 22391, Germany

Location

Dr. Bolze, Ludwigshafen, DE /ID# 254134

Ludwigshafen, 67069, Germany

Location

RHIO Forschungsinstitut /ID# 254752

Meerbusch, 40668, Germany

Location

Prof-med-stud.de /ID# 265965

Munich, 80935, Germany

Location

Knappschaftsklinikum Saar /ID# 255505

Püttlingen, 66346, Germany

Location

Krankenhaus St. Josef /ID# 254755

Wuppertal, 42105, Germany

Location

Olympion General Clinic /ID# 247644

Pátrai, Achaia, 25443, Greece

Location

251 Airforce General Hospital /ID# 248092

Athens, Attica, 11525, Greece

Location

Henry Dunnant Hospital Center /ID# 247640

Athens, Attica, 11526, Greece

Location

General Hospital of Athens Gennimatas /ID# 247635

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Ippokratio /ID# 247633

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 247634

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 258030

Athens, Attica, 11527, Greece

Location

University General Hospital Attikon /ID# 248093

Athens, Attica, 12462, Greece

Location

General Hospital of Elefsina Thriassio /ID# 251900

Magoula (Attikis), Attica, 19018, Greece

Location

Iaso /ID# 247649

Marousi, Attica, 15123, Greece

Location

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

Heraklion, Crete, 71500, Greece

Location

Naval Hospital of Athens /ID# 247631

Athens, 11521, Greece

Location

KAT Atttica General Hospital /ID# 247641

Athens, 14561, Greece

Location

University General Hospital of Ioannina /ID# 251899

Ioannina, 45500, Greece

Location

Iaso Thessalias S.A. /Id# 255110

Larissa, 41005, Greece

Location

Reg Gen Univ Hosp Larissa /ID# 247642

Larissa, 41110, Greece

Location

Bioclinic Thessaloniki /ID# 247648

Thessaloniki, 54622, Greece

Location

Euromedica Blue Cross Gen Clin /ID# 251898

Thessaloniki, 54636, Greece

Location

General Hospital of Thessaloniki Hippokrateio /ID# 247643

Thessaloniki, 54642, Greece

Location

Euromedica General Clinic /ID# 251897

Thessaloniki, 54645, Greece

Location

IRCCS Istituto Clinico Humanitas /ID# 251275

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Ospedale San Raffaele /ID# 251562

Milan, Milano, 20132, Italy

Location

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183

Naples, Napoli, 80138, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817

Rome, Roma, 00133, Italy

Location

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

Rome, Roma, 00168, Italy

Location

Azienda Ospedaliero Universitaria delle Marche /ID# 250819

Ancona, 60020, Italy

Location

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

Bari, 70124, Italy

Location

Universita degli Studi del Molise /ID# 251176

Campobasso, 86100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789

Palermo, 90127, Italy

Location

Fondazione IRCCS Policlinico San Matteo /ID# 250747

Pavia, 27100, Italy

Location

Azienda Ospedaliera Universitaria Senese /ID# 251146

Siena, 53100, Italy

Location

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

Udine, 33100, Italy

Location

Related Links

• Related info

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 15, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

GR (20); DE (19); FR (37); IT (12)