Psoriatic ArthritisUPtimum-PsANCT05616871
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
An observational study of Psoriatic Arthritis, run by AbbVie at 89 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 464 participants
- Where
- 89 sitesin 4 countries
- Study dates
- 15 Dec 2022to 11 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with Psoriatic Arthritis (PsA)
Who may be able to join
- 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.
Who cannot join
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- Prior treatment with upadacitinib.
Trial locations and contacts
89 sites in 4 countries.
89 sites in 4 countries
France38 sites
CH AIX LES BAIN - Reine Hortense /ID# 252465
Aix-les-Bains, 73100
Duplicate_CHU Amiens-Picardie Site Sud /ID# 252527
Amiens, Somme, 80054
Cabinet Medical Dr Albert-Sabonnadiere - Antibes /ID# 252523
Antibes, Provence-Alpes-Côte d'Azur Region, 06000
Centre Hospitalier d'Arras /ID# 252529
Arras, 62022
CH Henri Duffaut /ID# 252620
Avignon, Vaucluse, 84902
Ch Beauvais /Id# 252464
Beauvais, Oise, 60021
Duplicate_CHU de Besancon - Jean Minjoz /ID# 252537
Besançon, Doubs, 25030
CHU Bordeaux - Hopital Pellegrin /ID# 252532
Bordeaux, New Aquitaine, 33076
Centre Hospitalier de Boulogne Sur Mer /ID# 252467
Boulogne-sur-Mer, 62200
Centre Hospitalier Jean Rougie /ID# 259550
Cahors, 46005
Infirmerie Protestante De Lyon /ID# 252075
Caluire-et-Cuire, Auvergne-Rhône-Alpes, 69300
CH de Cannes - Simone Veil /ID# 252600
Cannes, 06400
Chic Castres-Mazamet /Id# 259557
Castres, Tarn, 81108
CHRU Tours - Hopital Trousseau /ID# 252528
Chambray-lès-Tours, 37170
C. H. Sud Francilien /ID# 254945
Corbeil-Essonnes, 91106
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194
Créteil, Paris, 94010
Duplicate_CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 259549
La Roche-sur-Yon, Vendee, 85000
CH La Rochelle - Hopital Saint Louis /ID# 252534
La Rochelle, 17019
CHU Grenoble - Hopital Michallon /ID# 252601
La Tronche, Isere, 38700
CHU Limoges - Dupuytren 1 /ID# 252432
Limoges, Franche-Comte, 87042
Hopital St Joseph - St Luc (Lyon) /ID# 259561
Lyon, 69007
Clinique de la Sauvegarde /ID# 252533
Lyon, 69009
ELSAN - Clinique du Pont de Chaume /ID# 252602
Montauban, 82000
CHU Montpellier - Hopital Saint Eloi /ID# 252078
Montpellier, Herault, 34295
CH de Narbonne /ID# 252525
Narbonne, 11100
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 252536
Nice, Alpes-Maritimes, 06001
Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 252530
Orléans, 45067
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 252526
Paris, 75010
AP-HP - Hopital Saint-Antoine /ID# 252627
Paris, 75012
AP-HP - Hopital Bichat - Claude-Bernard /ID# 252531
Paris, 75018
GH Diaconesses Croix Saint-Simon /ID# 252463
Paris, 75020
Cabinet libéral du Dr PAUPIERE /ID# 252604
Péronne, Somme, 80200
CHU de Rennes - Hospital Sud /ID# 252478
Rennes, 35203
Hôpital Charles-Nicolle /ID# 252603
Rouen, 76000
Cabinet Du Dr Judith Payet Dubourg /Id# 252668
Saint-Pierre-des-Corps, 97410
CHU Toulouse - Hopital Purpan /ID# 252077
Toulouse, Haute-Garonne, 31059
Clinique Médipôle Garonne /ID# 252462
Toulouse, 31036
Duplicate_CH Troyes - Hopital Simone Veil /ID# 252625
Troyes, Aube, 10000
Greece20 sites
251 Airforce General Hospital /ID# 248092
Athens, Attica, 11525
Henry Dunnant Hospital Center /ID# 247640
Athens, Attica, 11526
General Hospital of Athens Gennimatas /ID# 247635
Athens, Attica, 11527
General Hospital of Athens Laiko /ID# 247634
Athens, Attica, 11527
General Hospital of Athens Laiko /ID# 258030
Athens, Attica, 11527
Naval Hospital of Athens /ID# 247631
Athens, 11521
KAT Atttica General Hospital /ID# 247641
Athens, 14561
University General Hospital Attikon /ID# 248093
Chaïdári, Attica, 12462
University General Hospital of Heraklion PA.G.N.I /ID# 247632
Heraklion, Crete, 71500
University General Hospital of Ioannina /ID# 251899
Ioannina, 45500
Iaso Thessalias /ID# 255110
Larissa, Larisa, 41500
Reg Gen Univ Hosp Larissa /ID# 247642
Larissa, 41110
General Hospital of Elefsina Thriassio /ID# 251900
Magoula (Attikis), Attica, 19018
Iaso /ID# 247649
Marousi, Attica, 15123
Olympion General Clinic /ID# 247644
Pátrai, Achaia, 26443
General Hospital of Athens Ippokratio /ID# 247633
Thessaloniki, Attica, 11527
Bioclinic Thessaloniki /ID# 247648
Thessaloniki, 54622
Euromedica Blue Cross Gen Clin /ID# 251898
Thessaloniki, 54636
General Hospital of Thessaloniki Hippokrateio /ID# 247643
Thessaloniki, 54642
Euromedica General Clinic /ID# 251897
Thessaloniki, 54645
Germany19 sites
Kupka and Kupka, Altenburg, DE /ID# 254758
Altenburg, Thuringia, 04600
Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152
Berlin, 12161
Praxis Dr. Silke Zinke /ID# 258037
Berlin, 13055
MVZ Herzogin Elisabeth Hospital /ID# 266740
Braunschweig, 38114
Praxis Dilltal /ID# 254761
Ehringshausen, 35630
MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115
Erfurt, Thuringia, 99096
Universitaetsmedizin Greifswald /ID# 254756
Greifswald, 17475
Private Practice - Dr. Hauke E. Heintz /ID# 254757
Hamburg, 22391
Rheumazentrum Ruhrgebiet /ID# 252939
Herne, North Rhine-Westphalia, 44649
Beyer, Kaiserslautern, DE /ID# 254754
Kaiserslautern, Rhineland-Palatinate, 67659
Dr. Bolze, Ludwigshafen, DE /ID# 254134
Ludwigshafen, 67069
Aurich and Sieburg, Magdeburg /ID# 255504
Magdeburg, Saxony-Anhalt, 39104
RHIO Forschungsinstitut /ID# 254752
Meerbusch, 40668
Prof-med-stud.de /ID# 265965
Munich, 80935
Dr. Murawski /ID# 257911
Neunkirchen, Saarland, 66538
Rheumapraxis Dr. Prothmann /ID# 254759
Püttlingen, Saarland, 66346
Knappschaftsklinikum Saar /ID# 255505
Püttlingen, 66346
Krankenhaus der Barmherzigen Brüder Trier /ID# 254762
Trier, Rhineland-Palatinate, 54292
Krankenhaus St. Josef /ID# 254755
Wuppertal, 42105
Italy12 sites
Azienda Ospedaliero Universitaria delle Marche /ID# 250819
Ancona, 60126
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari /ID# 251508
Bari, 70124
Universita degli Studi del Molise /ID# 251176
Campobasso, 86100
IRCCS Ospedale San Raffaele /ID# 251562
Milan, Milano, 20132
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 251183
Naples, Napoli, 80138
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 250789
Palermo, 90127
Fondazione IRCCS Policlinico San Matteo /ID# 250747
Pavia, 27100
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250817
Rome, Roma, 00133
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 250669
Rome, Roma, 00168
IRCCS Istituto Clinico Humanitas /ID# 251275
Rozzano, Lombardy, 20089
Azienda Ospedaliera Universitaria Senese /ID# 251146
Siena, 53100
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 251544
Udine, 33100
About this study
Official title: 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.
Read more
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®
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start15 Dec 2022
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616871
- Sponsor's protocol ID
- P22-897
- Acronym
- UPtimum-PsA
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
- ClinicalTrials.gov ID
- NCT05616871
- Acronym / sponsor ID
- UPtimum-PsA / P22-897
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, PsA, UPA, Upadacitinib, Rinvoq®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with Psoriatic Arthritis (PsA)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- Prior treatment with upadacitinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
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Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
89 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by AbbVie at 89 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in France, Greece, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.