A Study to Assess the Change in Disease State in Adult Participants Being Treated With Oral Upadacitinib Tablets in Participants With Oligo- or Poly-artIcular Psoriatic Arthritis (UPJOINT)

July 16, 2024 updated by: AbbVie

Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity

Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. The main objective of this study is to characterize attainment of minimal disease activity (MDA) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular PsA as part of real-world practice.

Upadacitinib is a drug approved for the treatment of Psoriatic arthritis (PsA) in Germany and Canada. Approximately 380 adult participants with PsA at multiple sites in Germany and Canada.

Participants will receive oral Upadacitinib tablets per current local label, according to local standard of care and international guidelines.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

394

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1J9
        • Dr. Jonathan D. Chan Inc. /ID# 241611
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic /ID# 234148
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • The Waterside Clinic /ID# 234146
      • Dundas, Ontario, Canada, L9H 1B7
        • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565
      • Etobicoke, Ontario, Canada, M9C 5N2
        • Arthur Karasik Medicine Professional Corporation /ID# 234147
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Lau Bacchus Professional Medicine Corp /ID# 245283
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Rheumatology /ID# 234144
      • Oshawa, Ontario, Canada, L1H 1B9
        • Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 239611
      • Ottawa, Ontario, Canada, K1H 7X3
        • Angela Montgomery Medicine Professional Corporation /ID# 239608
      • St. Catharines, Ontario, Canada, L2N 7E4
        • Niagara Peninsula Arthritis Ct /ID# 245521
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696
    • Quebec
      • Montreal, Quebec, Canada, H4N 1C6
        • Clinique de Rhumatologie de Montreal /ID# 239613
      • Montréal, Quebec, Canada, H4A 3T2
        • Applied Medical Informatics Research Inc. (AMIR) /ID# 239614
      • Rimouski, Quebec, Canada, G5L 5T1
        • CISSSBSL -Hopital regional de Rimouski /ID# 234150
      • Sainte-foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses Inc /ID# 234145
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS /ID# 241054
      • Trois-rivières, Quebec, Canada, G8Z 1Y2
        • Centre de Recherche Musculo-Squelettique /ID# 234151
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 5M7
        • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 234149
  • Germany
      • Altenburg, Germany, 04600
        • Kupka & Kupka, Altenburg, DE /ID# 228243
      • Amberg, Germany, 92224
        • Marycz, Amberg, DE /ID# 227413
      • Augsburg, Germany, 86157
        • Rheumapraxis am Webereck /ID# 229274
      • Bad Pyrmont, Germany, 31812
        • MVZ Weserbergland /ID# 228806
      • Baden-baden, Germany, 76530
        • ACURA Rheumazentrum Baden-Bade /ID# 239202
      • Bamberg, Germany, 96047
        • Rheumapraxis Prof Dr Karin Manger /ID# 229120
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg /ID# 228549
      • Bayreuth, Germany, 95444
        • Internistische-rheumatologische Praxisgemeinschaft /ID# 228240
      • Berlin, Germany, 10117
        • MVZ Rheumatologie /ID# 240868
      • Berlin, Germany, 12555
        • Praxis Dr. med. Angela Seifert /ID# 233772
      • Berlin, Germany, 13055
        • Praxis Dr. Silke Zinke /ID# 229127
      • Berlin, Germany, 14129
        • Rheumapraxis am Schlachtensee /ID# 228800
      • Braunschweig, Germany, 38100
        • Eisterhues, Braunschweig, DE /ID# 227390
      • Coburg, Germany, 96450
        • Dres. Schuh /ID# 227411
      • Cologne, Germany, 50825
        • Rheumatologie in Veedel /ID# 228469
      • Cologne, Germany, 51149
        • Krankenhaus Porz am Rhein /ID# 228358
      • Deggendorf, Germany, 94469
        • Praxis Dr. Kirrstetter /ID# 229609
      • Demmin, Germany, 17109
        • Kreiskrankenhaus Demmin /ID# 228253
      • Dresden, Germany, 01109
        • Rheumatologisches MVZ Dresden /ID# 230787
      • Ehringshausen, Germany, 35630
        • Praxis Dilltal /ID# 228640
      • Erfurt, Germany, 99096
        • MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933
      • Essen, Germany, 45326
        • Dres. Waehrisch/Flaxenberg /ID# 228263
      • Freiberg, Germany, 09599
        • Michael Mueller, Freiberg, DE /ID# 228468
      • Fulda, Germany, 36039
        • Praxis Dr. Behringer /ID# 229275
      • Goslar, Germany, 38642
        • Rockwitz, Goslar, DE /ID# 227856
      • Greifswald, Germany, 17493
        • Praxis Fiene /ID# 244732
      • Haldensleben, Germany, 39340
        • Praxis Dr. Kuehne /ID# 229119
      • Halle, Germany, 06128
        • Praxis Dr. Liebhaber /ID# 228636
      • Hannover, Germany, 30161
        • Stille, Hanover, DE /ID# 229604
      • Heidelberg, Germany, 69120
        • Heilig, Heidelberg, DE /ID# 228356
      • Herne, Germany, 44649
        • St. Elisabeth Gruppe GmbH -Katholische Kliniken /ID# 228797
      • Homburg, Germany, 66424
        • Praxis Bernd Mueller /ID# 230776
      • Hoppegarten, Germany, 15366
        • Praxis K. Pagel /ID# 228247
      • Juelich, Germany, 52428
        • Kremers, Juelich, DE /ID# 240383
      • Kaufering, Germany, 86916
        • Rheumapraxis Kaufering /ID# 231391
      • Langenau, Germany, 89129
        • Alb-Donau Klinikum, Langenau /ID# 233770
      • Leipzig, Germany, 04109
        • Hamann & Teich & Boche,Leipzig /ID# 228355
      • Leipzig, Germany, 04129
        • Praxis internistische Rheumatologie /ID# 227857
      • Leverkusen, Germany, 51373
        • Dres. Teipel/Toussaint/Saech /ID# 228465
      • Ludwigshafen, Germany, 67069
        • Dr. Bolze, Ludwigshafen, DE /ID# 230773
      • Magdeburg, Germany, 39104
        • Aurich & Sieburg, Magdeburg /ID# 229605
      • Mansfeld / Großörner, Germany, 06343
        • Praxis Dr. Annekatrin Rossbach /ID# 230783
      • Marktredwitz, Germany, 95615
        • Harmuth, Marktredwitz, DE /ID# 227709
      • Meerbusch, Germany, 40668
        • RHIO Forschungsinstitut /ID# 227736
      • Moenchengladbach, Germany, 41061
        • Vollmer & Partner, DE /ID# 240869
      • Munich, Germany, 80935
        • Prof-med-stud.de /ID# 228637
      • Naumburg (Saale), Germany, 06618
        • Rheumatologische Facharztpraxis /ID# 228808
      • Naunhof, Germany, 04683
        • Berger, Naunhof, DE /ID# 229612
      • Neubrandenburg, Germany, 17033
        • Praxis Dr. med Thilo Klopsch /ID# 229123
      • Neunkirchen, Germany, 66538
        • Erbsloeh-Moeller, Neunkirchen /ID# 230778
      • Nuremberg, Germany, 90443
        • MVZ Medic-Center Nürnberg GmbH /ID# 240982
      • Pfarrkirchen, Germany, 84347
        • Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 230774
      • Planegg, Germany, 82152
        • MVZ für Rheumatologie Dr. M. Welcker /ID# 227858
      • Plauen, Germany, 08523
        • Baumann & Lang, Plauen, DE /ID# 229128
      • Potsdam, Germany, 14469
        • Praxis Dr. Sabine Reckert /ID# 248986
      • Puettlingen, Germany, 66346
        • Knappschaftsklinikum Saar /ID# 248882
      • Ratingen, Germany, 40882
        • Rheumazentrum Ratingen /ID# 228261
      • Rendsburg, Germany, 24768
        • Rheumatologische Praxis Dr. Jochen Walter /ID# 229607
      • Schwerin, Germany, 19053
        • Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260
      • Seesen, Germany, 38723
        • Melzer, Seesen, DE /ID# 227386
      • Straubing, Germany, 94315
        • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brueder Trier /ID# 229603
      • Tuebingen, Germany, 72072
        • Praxis Dr. Haas /ID# 228813
      • Ulm, Germany, 89073
        • Rheumathologie Ulm /ID# 238801
      • Wetzlar, Germany, 35578
        • MVZ Lahn-Dill-Kliniken GmbH /ID# 231390
      • Wetzlar, Germany, 35578
        • MVZ Lahn-Dill-Kliniken GmbH /ID# 262011
      • Wuppertal, Germany, 42105
        • Krankenhaus St. Josef /ID# 229611
      • Wuppertal, Germany, 42285
        • Praxis Barmen /ID# 227392
      • Zeven, Germany, 27404
        • Sprekeler, Zeven, DE /ID# 233773
      • Zwickau, Germany, 08060
        • Fricke-Wagner, Zwickau, DE /ID# 230775
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany, 89073
        • Praxis Dr. Rinaldi /ID# 228639
    • Bayern
      • Munich, Bayern, Germany, 81541
        • Praxis Dres. Kellerer/Kellerer/Krüger /ID# 227414
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Rheumahaus Studien GbR, Potsdam, DE /ID# 230771
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Internistisches Praxiszentrum /ID# 228262
    • Niedersachsen
      • Bruchhausen-Vilsen, Niedersachsen, Germany, 27305
        • Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391

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

Participants with psoriatic arthritis (PsA).

Description

Inclusion Criteria:

  • Diagnosis of active Psoriatic Arthritis (PsA) upon judgment of the treating physician.
  • Swollen joint count (SJC) >= 1 out of 66 joints.
  • Decision on the treatment with Upadacitinib was made prior to any decision to approach the participant to participate in this study.

Exclusion Criteria:

  • Cannot be treated with Upadacitinib according to the local Upadacitinib Summary of Product Characteristics (SmPC).
  • Prior treatment with Upadacitinib.
  • Currently participating in interventional research or within the last 30 days.

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
Participants Receiving Upadacitinib
Participants receiving Upadacitinib for psoriatic arthritis (PsA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)
Time Frame: At Week 24
MDA will be determined based on participants fulfilling 5 of 7 outcome measures: tender joint count 68 (TJC68) <= 1, swollen joint count (SJC66) ≤ 1, body surface area (BSA) <= 3%; Patient's Assessment of Pain numeric rating scale (NRS) <= 1.5, Patient's Global Assessment of Disease Activity (PtGA) NRS <= 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI) <= 0.5, tender entheseal points <= 1.
At Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24
Time Frame: At Week 48
MDA will be determined based on participants fulfilling 5 of 7 outcome measures: TJC68 <= 1, SJC66 ≤ 1, BSA <= 3%; Patient's Assessment of Pain NRS <= 1.5, PtGA NRS <= 2.0, HAQ-DI <= 0.5, tender entheseal points <= 1.
At Week 48
Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip)
Time Frame: Baseline to Week 48
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem).
Baseline to Week 48
Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA)
Time Frame: Baseline to Week 48
The DAPSA is a numerical sum of the 66 swollen and 68 tender joint counts, the participant pain and global assessments (each on a 0-10 scale) and C-reactive protein (CRP) (in mg/dL), thus ranging from 0 to about 160.
Baseline to Week 48
Mean Change in Percentage of Participants with Dactylitis
Time Frame: Baseline to Week 48
Mean change in percentage of participants with dactylitis.
Baseline to Week 48
Mean Change in Number of Fingernails Affected with Psoriasis
Time Frame: Baseline to Week 48
Mean change in number of fingernails affected with psoriasis.
Baseline to Week 48
Mean Change in 12-Item Short Form Health Survey (SF-12)
Time Frame: Baseline to Week 48
The SF-12 is a 12-item, patient-reported, generic, non-disease specific, overall HRQoL instrument with extensive use in multiple disease states.
Baseline to Week 48
Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement]
Time Frame: Baseline to Week 48
The DLQI consists of 10 questions concerning participants' perception of the impact of the skin disease on different aspects of their HRQoL over the previous week.
Baseline to Week 48

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)

February 4, 2021

Primary Completion (Actual)

July 26, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-483

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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