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)

March 28, 2024 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

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 Contact

Study Locations

  • France
      • Aix Les Bains, France, 73100
        • Recruiting
        • CH AIX LES BAIN - Reine Hortense /ID# 252465
      • Antibes, France, 06000
        • Recruiting
        • Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523
      • Arras, France, 62022
        • Recruiting
        • Centre Hospitalier d'Arras /ID# 252529
      • Boulogne sur Mer, France, 62200
        • Recruiting
        • Centre Hospitalier de Boulogne Sur Mer /ID# 252467
      • Cannes, France, 06400
        • Recruiting
        • CH de Cannes - Simone Veil /ID# 252600
      • Chambray Les Tours, France, 37170
        • Recruiting
        • CHRU Tours - Hopital Trousseau /ID# 252528
      • Corbeil Essonnes, France, 91106
        • Recruiting
        • C. H. Sud Francilien /ID# 254945
      • La Rochelle, France, 17019
        • Recruiting
        • CH La Rochelle - Hopital Saint Louis /ID# 252534
      • La Tronche, France, 38700
        • Recruiting
        • CHU Grenoble - Hopital Michallon /ID# 252601
      • Montauban, France, 82000
        • Recruiting
        • ELSAN - Clinique du Pont de Chaume /ID# 252602
      • Narbonne, France, 11100
        • Recruiting
        • CH de Narbonne /ID# 252525
      • Orléans, France, 45067
        • Recruiting
        • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530
      • Paris, France, 75020
        • Recruiting
        • GH Diaconesses Croix Saint-Simon /ID# 252463
      • Rennes CEDEX 2, France, 35203
        • Recruiting
        • CHU de Rennes - Hospital Sud /ID# 252478
      • Rouen, France, 76000
        • Recruiting
        • Hôpital Charles-Nicolle /ID# 252603
      • St Pierre, France, 97410
        • Recruiting
        • Cabinet Du Dr Judith Payet Dubourg /Id# 252668
    • Aube
      • Troyes, Aube, France, 10000
        • Recruiting
        • CH Troyes - Hopital Simone Veil /ID# 252625
    • Franche-Comte
      • Limoges CEDEX 1, Franche-Comte, France, 87042
        • Recruiting
        • CHU Limoges - Dupuytren 1 /ID# 252432
    • Gironde
      • Bordeaux CEDEX, Gironde, France, 33076
        • Recruiting
        • CHU Bordeaux - Hopital Pellegrin /ID# 252532
    • Haute-Garonne
      • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
        • Recruiting
        • CHU Toulouse - Hopital Purpan /ID# 252077
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • Recruiting
        • CHU Montpellier - Hôpital Saint Eloi /ID# 252078
    • Oise
      • Beauvais CEDEX, Oise, France, 60021
        • Recruiting
        • Ch Beauvais /Id# 252464
    • Provence-Alpes-Cote-d Azur
      • Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
        • Recruiting
        • CHU Nice -Hopital Pasteur /ID# 252536
    • Rhone
      • Caluire Et Cuire, Rhone, France, 69300
        • Recruiting
        • Infirmerie Protestante /ID# 252075
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • Recruiting
        • CHU Amiens-Picardie Site Sud /ID# 252527
      • Peronne, Somme, France, 80200
        • Recruiting
        • Cabinet libéral du Dr PAUPIERE /ID# 252604
    • Vaucluse
      • Avignon CEDEX 9, Vaucluse, France, 84902
        • Recruiting
        • CH Henri Duffaut /ID# 252620
  • Germany
      • Altenburg, Germany, 04600
        • Recruiting
        • Kupka & Kupka, Altenburg, DE /ID# 254758
      • Berlin, Germany, 13055
        • Recruiting
        • Praxis Dr. Silke Zinke /ID# 258037
      • Berlin, Germany, 12161
        • Recruiting
        • Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
      • Ehringshausen, Germany, 35630
        • Recruiting
        • Praxis Dilltal /ID# 254761
      • Erfurt, Germany, 99096
        • Recruiting
        • MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115
      • Greifswald, Germany, 17475
        • Recruiting
        • Universitaetsmedizin Greifswald /ID# 254756
      • Hamburg, Germany, 22391
        • Recruiting
        • Dr. Heintz /ID# 254757
      • Herne, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet /ID# 252939
      • Kaiserslautern, Germany, 67659
        • Active, not recruiting
        • Beyer, Kaiserslautern, DE /ID# 254754
      • Ludwigshafen, Germany, 67069
        • Completed
        • Dr. Bolze, Ludwigshafen, DE /ID# 254134
      • Magdeburg, Germany, 39104
        • Recruiting
        • Aurich & Sieburg, Magdeburg /ID# 255504
      • Meerbusch, Germany, 40668
        • Recruiting
        • RHIO Forschungsinstitut /ID# 254752
      • Munich, Germany, 80935
        • Recruiting
        • Prof-med-stud.de /ID# 265965
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier /ID# 254762
      • Wuppertal, Germany, 42105
        • Recruiting
        • Krankenhaus St. Josef /ID# 254755
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • Recruiting
        • Dr. Murawski /ID# 257911
  • Greece
      • Athens, Greece, 11521
        • Recruiting
        • Naval Hospital of Athens /ID# 247631
      • Athens, Greece, 14561
        • Recruiting
        • KAT Atttica General Hospital /ID# 247641
      • Ioannina, Greece, 45500
        • Recruiting
        • University General Hospital of Ioannina /ID# 251899
      • Larisa, Greece, 41110
        • Recruiting
        • Reg Gen Univ Hosp Larissa /ID# 247642
      • Larisa, Greece, 41005
        • Recruiting
        • Iaso Thessalias S.A. /Id# 255110
      • Magoula (Attikis), Greece, 19018
        • Completed
        • General Hospital of Elefsina Thriassio /ID# 251900
      • Maroussi, Greece, 15123
        • Recruiting
        • Iaso /ID# 247649
      • Patras, Greece, 26443
        • Recruiting
        • Olympion General Clinic SA /ID# 247644
      • Thessaloniki, Greece, 54636
        • Recruiting
        • Euromedica Blue Cross Gen Clin /ID# 251898
      • Thessaloniki, Greece, 54642
        • Recruiting
        • General Hospital of Thessaloniki Hippokrateio /ID# 247643
      • Thessaloniki, Greece, 54622
        • Recruiting
        • Bioclinic Thessaloniki /ID# 247648
      • Thessaloniki, Greece, 54645
        • Recruiting
        • Euromedica General Clinic /ID# 251897
    • Attiki
      • Athens, Attiki, Greece, 12462
        • Recruiting
        • University General Hospital Attikon /ID# 248093
      • Athens, Attiki, Greece, 11525
        • Recruiting
        • 251 Airforce General Hospital /ID# 248092
      • Athens, Attiki, Greece, 11526
        • Recruiting
        • Henry Dunnant Hospital Center /ID# 247640
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • General Hospital of Athens Gennimatas /ID# 247635
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • General Hospital of Athens Ippokratio /ID# 247633
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • General Hospital of Athens Laiko /ID# 247634
      • Athens, Attiki, Greece, 11527
        • Active, not recruiting
        • General Hospital of Athens Laiko /ID# 258030
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • Recruiting
        • University General Hospital of Heraklion PA.G.N.I /ID# 247632
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 251508
      • Campobasso, Italy, 86100
        • Recruiting
        • Universita degli Studi del Molise /ID# 251176
      • Napoli, Italy, 80138
        • Recruiting
        • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251183
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 250789
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico /ID# 250747
      • Siena, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 251146
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544
    • Ancona
      • Torette, Ancona, Italy, 60020
        • Recruiting
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 250819
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669
    • Milano
      • Milan, Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele IRCCS /ID# 251562
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas /ID# 251275
    • Roma
      • Rome, Roma, Italy, 00133
        • Recruiting
        • Fondazione PTV Policlinico Tor Vergata /ID# 250817

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)

June 14, 2026

Study Completion (Estimated)

July 31, 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 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

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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