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 (UPtimum-PsA)

January 9, 2025 updated by: AbbVie

Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix Les Bains, France, 73100
        • CH AIX LES BAIN - Reine Hortense /ID# 252465
      • Antibes, France, 06000
        • Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523
      • Arras, France, 62022
        • Centre Hospitalier d'Arras /ID# 252529
      • Boulogne sur Mer, France, 62200
        • Centre Hospitalier de Boulogne Sur Mer /ID# 252467
      • Cahors, France, 46005
        • Centre Hospitalier Jean Rougie /ID# 259550
      • Cannes, France, 06400
        • CH de Cannes - Simone Veil /ID# 252600
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 252528
      • Corbeil Essonnes, France, 91106
        • C. H. Sud Francilien /ID# 254945
      • La Rochelle, France, 17019
        • CH La Rochelle - Hopital Saint Louis /ID# 252534
      • Lyon, France, 69007
        • Hopital St Joseph - St Luc (Lyon) /ID# 259561
      • Lyon, France, 69009
        • Clinique de la Sauvegarde /ID# 252533
      • Montauban, France, 82000
        • ELSAN - Clinique du Pont de Chaume /ID# 252602
      • Narbonne, France, 11100
        • CH de Narbonne /ID# 252525
      • Orléans, France, 45067
        • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530
      • Paris, France, 75010
        • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 252526
      • Paris, France, 75012
        • AP-HP - Hopital Saint-Antoine /ID# 252627
      • Paris, France, 75018
        • AP-HP - Hopital Bichat - Claude-Bernard /ID# 252531
      • Paris, France, 75020
        • GH Diaconesses Croix Saint-Simon /ID# 252463
      • Rennes CEDEX 2, France, 35203
        • CHU de Rennes - Hospital Sud /ID# 252478
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle /ID# 252603
      • St Pierre, France, 97410
        • Cabinet Du Dr Judith Payet Dubourg /Id# 252668
    • Alpes-Maritimes
      • Nice CEDEX 1, Alpes-Maritimes, France, 06001
        • Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536
    • Aube
      • Troyes, Aube, France, 10000
        • CH Troyes - Hopital Simone Veil /ID# 252625
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU de Besancon - Jean Minjoz /ID# 252537
    • Franche-Comte
      • Limoges CEDEX 1, Franche-Comte, France, 87042
        • CHU Limoges - Dupuytren 1 /ID# 252432
    • Haute-Garonne
      • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
        • CHU Toulouse - Hopital Purpan /ID# 252077
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 252078
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 252601
    • Nouvelle-Aquitaine
      • Bordeaux, Nouvelle-Aquitaine, France, 33076
        • CHU Bordeaux - Hopital Pellegrin /ID# 252532
    • Oise
      • Beauvais CEDEX, Oise, France, 60021
        • Ch Beauvais /Id# 252464
    • Paris
      • Creteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
    • Rhone
      • Caluire Et Cuire, Rhone, France, 69300
        • Infirmerie Protestante /ID# 252075
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 252527
      • Peronne, Somme, France, 80200
        • Cabinet libéral du Dr PAUPIERE /ID# 252604
    • Tarn
      • Castres CEDEX, Tarn, France, 81108
        • Chic Castres-Mazamet /Id# 259557
    • Vaucluse
      • Avignon CEDEX 9, Vaucluse, France, 84902
        • CH Henri Duffaut /ID# 252620
    • Vendee
      • La Roche Sur Yon, Vendee, France, 85000
        • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549
  • Germany
      • Altenburg, Germany, 04600
        • Kupka & Kupka, Altenburg, DE /ID# 254758
      • Berlin, Germany, 12161
        • Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
      • Berlin, Germany, 13055
        • Praxis Dr. Silke Zinke /ID# 258037
      • Brunswick, Germany, 38114
        • MVZ Herzogin Elisabeth Hospital /ID# 266740
      • Ehringshausen, Germany, 35630
        • Praxis Dilltal /ID# 254761
      • Greifswald, Germany, 17475
        • Universitaetsmedizin Greifswald /ID# 254756
      • Hamburg, Germany, 22391
        • Dr. Heintz /ID# 254757
      • Ludwigshafen, Germany, 67069
        • Dr. Bolze, Ludwigshafen, DE /ID# 254134
      • Meerbusch, Germany, 40668
        • RHIO Forschungsinstitut /ID# 254752
      • Munich, Germany, 80935
        • Prof-med-stud.de /ID# 265965
      • Puettlingen, Germany, 66346
        • Knappschaftsklinikum Saar /ID# 255505
      • Wuppertal, Germany, 42105
        • Krankenhaus St. Josef /ID# 254755
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 252939
    • Rheinland-Pfalz
      • Kaiserslautern, Rheinland-Pfalz, Germany, 67659
        • Beyer, Kaiserslautern, DE /ID# 254754
      • Trier, Rheinland-Pfalz, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier /ID# 254762
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • Dr. Murawski /ID# 257911
      • Püttlingen, Saarland, Germany, 66346
        • Rheumapraxis Dr. Prothmann /ID# 254759
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
        • Aurich & Sieburg, Magdeburg /ID# 255504
    • Thueringen
      • Erfurt, Thueringen, Germany, 99096
        • MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115
  • Greece
      • Athens, Greece, 11521
        • Naval Hospital of Athens /ID# 247631
      • Athens, Greece, 14561
        • KAT Atttica General Hospital /ID# 247641
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 251899
      • Larisa, Greece, 41005
        • Iaso Thessalias S.A. /Id# 255110
      • Larisa, Greece, 41110
        • Reg Gen Univ Hosp Larissa /ID# 247642
      • Thessaloniki, Greece, 54622
        • Bioclinic Thessaloniki /ID# 247648
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Hippokrateio /ID# 247643
      • Thessaloniki, Greece, 54636
        • Euromedica Blue Cross Gen Clin /ID# 251898
      • Thessaloniki, Greece, 54645
        • Euromedica General Clinic /ID# 251897
    • Achaia
      • Patras, Achaia, Greece, 25443
        • Olympion General Clinic /ID# 247644
    • Attiki
      • Athens, Attiki, Greece, 11525
        • 251 Airforce General Hospital /ID# 248092
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Gennimatas /ID# 247635
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 247633
      • Athens, Attiki, Greece, 12462
        • University General Hospital Attikon /ID# 248093
      • Athens, Attiki, Greece, 11526
        • Henry Dunnant Hospital Center /ID# 247640
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 247634
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 258030
      • Magoula (Attikis), Attiki, Greece, 19018
        • General Hospital of Elefsina Thriassio /ID# 251900
      • Maroussi, Attiki, Greece, 15123
        • Iaso /ID# 247649
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 247632
  • Italy
      • Ancona, Italy, 60020
        • Azienda Ospedaliero Universitaria delle Marche /ID# 250819
      • Bari, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari /ID# 251508
      • Campobasso, Italy, 86100
        • Universita degli Studi del Molise /ID# 251176
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo /ID# 250747
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese /ID# 251146
      • Udine, Italy, 33100
        • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • IRCCS Istituto Clinico Humanitas /ID# 251275
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 251562
    • Napoli
      • Naples, Napoli, Italy, 80138
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183
    • Roma
      • Rome, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with Psoriatic Arthritis (PsA)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14
Time Frame: 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].
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P22-897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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