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)

July 24, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Aix-les-Bains, France, 73100
        • CH AIX LES BAIN - Reine Hortense /ID# 252465
      • 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-lès-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 Regional d Orleans - Hopital 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, France, 35203
        • CHU de Rennes - Hospital Sud /ID# 252478
      • Rouen, France, 76000
        • Hôpital Charles-Nicolle /ID# 252603
      • Saint-Pierre-des-Corps, France, 97410
        • Cabinet Du Dr Judith Payet Dubourg /Id# 252668
      • Toulouse, France, 31036
        • Clinique Médipôle Garonne /ID# 252462
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 252536
    • Aube
      • Troyes, Aube, France, 10000
        • Duplicate_CH Troyes - Hopital Simone Veil /ID# 252625
    • Auvergne-Rhône-Alpes
      • Caluire-et-Cuire, Auvergne-Rhône-Alpes, France, 69300
        • Infirmerie Protestante De Lyon /ID# 252075
    • Doubs
      • Besançon, Doubs, France, 25030
        • Duplicate_CHU de Besancon - Jean Minjoz /ID# 252537
    • Franche-Comte
      • Limoges, Franche-Comte, France, 87042
        • CHU Limoges - Dupuytren 1 /ID# 252432
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • CHU Toulouse - Hopital Purpan /ID# 252077
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 252078
    • Isere
      • La Tronche, Isere, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 252601
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • CHU Bordeaux - Hopital Pellegrin /ID# 252532
    • Oise
      • Beauvais, Oise, France, 60021
        • Ch Beauvais /Id# 252464
    • Paris
      • Créteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
    • Provence-Alpes-Côte d'Azur Region
      • Antibes, Provence-Alpes-Côte d'Azur Region, France, 06000
        • Cabinet Medical Dr Albert-Sabonnadiere - Antibes /ID# 252523
    • Somme
      • Amiens, Somme, France, 80054
        • Duplicate_CHU Amiens-Picardie Site Sud /ID# 252527
      • Péronne, Somme, France, 80200
        • Cabinet libéral du Dr PAUPIERE /ID# 252604
    • Tarn
      • Castres, Tarn, France, 81108
        • Chic Castres-Mazamet /Id# 259557
    • Vaucluse
      • Avignon, Vaucluse, France, 84902
        • CH Henri Duffaut /ID# 252620
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85000
        • Duplicate_CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549
  • Germany
      • Berlin, Germany, 12161
        • Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
      • Berlin, Germany, 13055
        • Praxis Dr. Silke Zinke /ID# 258037
      • Braunschweig, 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
        • Private Practice - Dr. Hauke E. 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
      • Püttlingen, Germany, 66346
        • Knappschaftsklinikum Saar /ID# 255505
      • Wuppertal, Germany, 42105
        • Krankenhaus St. Josef /ID# 254755
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 252939
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67659
        • Beyer, Kaiserslautern, DE /ID# 254754
      • Trier, Rhineland-Palatinate, 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
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39104
        • Aurich and Sieburg, Magdeburg /ID# 255504
    • Thuringia
      • Altenburg, Thuringia, Germany, 04600
        • Kupka and Kupka, Altenburg, DE /ID# 254758
      • Erfurt, Thuringia, 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
      • Larissa, 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
      • Pátrai, Achaia, Greece, 26443
        • Olympion General Clinic /ID# 247644
    • Attica
      • Athens, Attica, Greece, 11525
        • 251 Airforce General Hospital /ID# 248092
      • Athens, Attica, Greece, 11526
        • Henry Dunnant Hospital Center /ID# 247640
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Gennimatas /ID# 247635
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 247634
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 258030
      • Chaïdári, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 248093
      • Magoula (Attikis), Attica, Greece, 19018
        • General Hospital of Elefsina Thriassio /ID# 251900
      • Marousi, Attica, Greece, 15123
        • Iaso /ID# 247649
      • Thessaloniki, Attica, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 247633
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 247632
    • Larisa
      • Larissa, Larisa, Greece, 41500
        • Iaso Thessalias /ID# 255110
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria delle Marche /ID# 250819
      • Bari, Italy, 70124
        • Azienda Ospedaliero-Universitaria 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
        • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 251544
    • Lombardy
      • Rozzano, Lombardy, 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-Universita 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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