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Psoriatic ArthritisUPJOINTNCT04758117

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

An observational study of Psoriatic Arthritis, run by AbbVie at 93 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
How many people
394 participants
Where
93 sitesin 2 countries
Study dates
4 Feb 2021to 26 Jul 2023
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: Participants with psoriatic arthritis (PsA).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

93 sites in 2 countries.

93 sites in 2 countries

Germany75 sites

  • Kupka & Kupka, Altenburg, DE /ID# 228243

    Altenburg, 04600

  • Marycz, Amberg, DE /ID# 227413

    Amberg, 92224

  • Rheumapraxis am Webereck /ID# 229274

    Augsburg, 86157

  • MVZ Weserbergland /ID# 228806

    Bad Pyrmont, 31812

  • ACURA Rheumazentrum Baden-Bade /ID# 239202

    Baden-Baden, 76530

  • Rheumapraxis Prof Dr Karin Manger /ID# 229120

    Bamberg, 96047

  • Sozialstiftung Bamberg /ID# 228549

    Bamberg, 96049

  • Internistische-rheumatologische Praxisgemeinschaft /ID# 228240

    Bayreuth, 95444

  • MVZ Rheumatologie /ID# 240868

    Berlin, 10117

  • Praxis Dr. med. Angela Seifert /ID# 233772

    Berlin, 12555

  • Praxis Dr. Silke Zinke /ID# 229127

    Berlin, 13055

  • Rheumapraxis am Schlachtensee /ID# 228800

    Berlin, 14129

  • Eisterhues, Braunschweig, DE /ID# 227390

    Braunschweig, 38100

  • Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391

    Bruchhausen-Vilsen, Lower Saxony, 27305

  • Dres. Schuh /ID# 227411

    Coburg, 96450

  • Rheumatologie in Veedel /ID# 228469

    Cologne, 50825

  • Krankenhaus Porz am Rhein /ID# 228358

    Cologne, 51149

  • Praxis Dr. Kirrstetter /ID# 229609

    Deggendorf, 94469

  • Kreiskrankenhaus Demmin /ID# 228253

    Demmin, 17109

  • Rheumatologisches MVZ Dresden /ID# 230787

    Dresden, 01109

  • Praxis Dilltal /ID# 228640

    Ehringshausen, 35630

  • MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933

    Erfurt, 99096

  • Dres. Waehrisch/Flaxenberg /ID# 228263

    Essen, 45326

  • Michael Mueller, Freiberg, DE /ID# 228468

    Freiberg, 09599

  • Praxis Dr. Behringer /ID# 229275

    Fulda, 36039

  • Internistisches Praxiszentrum /ID# 228262

    Giessen, Hesse, 35392

  • Rockwitz, Goslar, DE /ID# 227856

    Goslar, 38642

  • Praxis Fiene /ID# 244732

    Greifswald, 17493

  • Praxis Dr. Kuehne /ID# 229119

    Haldensleben I, 39340

  • Praxis Dr. Liebhaber /ID# 228636

    Halle, 06128

  • Stille, Hanover, DE /ID# 229604

    Hanover, 30161

  • Heilig, Heidelberg, DE /ID# 228356

    Heidelberg, 69120

  • St. Elisabeth Gruppe GmbH -Katholische Kliniken /ID# 228797

    Herne, 44649

  • Praxis Bernd Mueller /ID# 230776

    Homburg, 66424

  • Praxis K. Pagel /ID# 228247

    Hoppegarten, 15366

  • Kremers, Juelich, DE /ID# 240383

    Jülich, 52428

  • Rheumapraxis Kaufering /ID# 231391

    Kaufering, 86916

  • Alb-Donau Klinikum, Langenau /ID# 233770

    Langenau, 89129

  • Hamann & Teich & Boche,Leipzig /ID# 228355

    Leipzig, 04109

  • Praxis internistische Rheumatologie /ID# 227857

    Leipzig, 04129

  • Dres. Teipel/Toussaint/Saech /ID# 228465

    Leverkusen, 51373

  • Dr. Bolze, Ludwigshafen, DE /ID# 230773

    Ludwigshafen, 67069

  • Aurich & Sieburg, Magdeburg /ID# 229605

    Magdeburg, 39104

  • Praxis Dr. Annekatrin Rossbach /ID# 230783

    Mansfeld / Großörner, 06343

  • Harmuth, Marktredwitz, DE /ID# 227709

    Marktredwitz, 95615

  • RHIO Forschungsinstitut /ID# 227736

    Meerbusch, 40668

  • Vollmer & Partner, DE /ID# 240869

    Mönchengladbach, 41061

  • Praxis Dres. Kellerer/Kellerer/Krüger /ID# 227414

    Munich, Bavaria, 81541

  • Prof-med-stud.de /ID# 228637

    Munich, 80935

  • Rheumatologische Facharztpraxis /ID# 228808

    Naumburg, 06618

  • Berger, Naunhof, DE /ID# 229612

    Naunhof, 04683

  • Praxis Dr. med Thilo Klopsch /ID# 229123

    Neubrandenburg, 17033

  • Erbsloeh-Moeller, Neunkirchen /ID# 230778

    Neunkirchen, 66538

  • MVZ Medic-Center Nürnberg GmbH /ID# 240982

    Nuremberg, 90443

  • Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 230774

    Pfarrkirchen, 84347

  • MVZ für Rheumatologie Dr. M. Welcker /ID# 227858

    Planegg, 82152

  • Baumann & Lang, Plauen, DE /ID# 229128

    Plauen, 08523

  • Rheumahaus Studien GbR, Potsdam, DE /ID# 230771

    Potsdam, Brandenburg, 14467

  • Praxis Dr. Sabine Reckert /ID# 248986

    Potsdam, 14469

  • Knappschaftsklinikum Saar /ID# 248882

    Püttlingen, 66346

  • Rheumazentrum Ratingen /ID# 228261

    Ratingen, 40882

  • Rheumatologische Praxis Dr. Jochen Walter /ID# 229607

    Rendsburg, 24768

  • Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260

    Schwerin, 19053

  • Melzer, Seesen, DE /ID# 227386

    Seesen, 38723

  • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805

    Straubing, 94315

  • Krankenhaus der Barmherzigen Brueder Trier /ID# 229603

    Trier, 54292

  • Praxis Dr. Haas /ID# 228813

    Tübingen, 72072

  • Praxis Dr. Rinaldi /ID# 228639

    Ulm, Baden-Wurttemberg, 89073

  • Rheumathologie Ulm /ID# 238801

    Ulm, 89073

  • MVZ Lahn-Dill-Kliniken GmbH /ID# 231390

    Wetzlar, 35578

  • MVZ Lahn-Dill-Kliniken GmbH /ID# 262011

    Wetzlar, 35578

  • Krankenhaus St. Josef /ID# 229611

    Wuppertal, 42105

  • Praxis Barmen /ID# 227392

    Wuppertal, 42285

  • Sprekeler, Zeven, DE /ID# 233773

    Zeven, 27404

  • Fricke-Wagner, Zwickau, DE /ID# 230775

    Zwickau, 08060

Other trials in Germany

Canada18 sites

  • The Waterside Clinic /ID# 234146

    Barrie, Ontario, L4M 6L2

  • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565

    Dundas, Ontario, L9H 1B7

  • Arthur Karasik Medicine Professional Corporation /ID# 234147

    Etobicoke, Ontario, M9C 5N2

  • Lau Bacchus Professional Medicine Corp /ID# 245283

    Hamilton, Ontario, L8N 1Y2

  • Credit Valley Rheumatology /ID# 234144

    Mississauga, Ontario, L5M 2V8

  • Applied Medical Informatics Research Inc. (AMIR) /ID# 239614

    Montreal, Quebec, H4A 3T2

  • Clinique de Rhumatologie de Montreal /ID# 239613

    Montreal, Quebec, H4N 1C6

  • Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 239611

    Oshawa, Ontario, L1H 1B9

  • Angela Montgomery Medicine Professional Corporation /ID# 239608

    Ottawa, Ontario, K1H 7X3

  • CISSSBSL -Hopital regional de Rimouski /ID# 234150

    Rimouski, Quebec, G5L 5T1

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 234145

    Sainte-Foy, Quebec, G1V 3M7

  • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 234149

    Saskatoon, Saskatchewan, S7H 5M7

  • CIUSSS de l'Estrie - CHUS /ID# 241054

    Sherbrooke, Quebec, J1G 2E8

  • Niagara Peninsula Arthritis Ct /ID# 245521

    St. Catharines, Ontario, L2N 7E4

  • Centre de Recherche Musculo-Squelettique /ID# 234151

    Trois-Rivières, Quebec, G8Z 1Y2

  • Dr. Jonathan D. Chan Inc. /ID# 241611

    Vancouver, British Columbia, V5Z 1J9

  • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696

    Windsor, Ontario, N8X 1T3

  • Manitoba Clinic /ID# 234148

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Keywords
Psoriatic Arthritis, Oligoarticular Psoriatic Arthritis, Polyarticular Psoriatic Arthritis, 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 groups in NCT04758117
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving Upadacitinib for psoriatic arthritis (PsA).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)

    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.

    Measured: At Week 24

Secondary outcomes (7)

  1. Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24

    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.

    Measured: At Week 48

  2. Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip)

    The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem).

    Measured: Baseline to Week 48

  3. Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA)

    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.

    Measured: Baseline to Week 48

  4. Mean Change in Percentage of Participants with Dactylitis

    Mean change in percentage of participants with dactylitis.

    Measured: Baseline to Week 48

  5. Mean Change in Number of Fingernails Affected with Psoriasis

    Mean change in number of fingernails affected with psoriasis.

    Measured: Baseline to Week 48

  6. Mean Change in 12-Item Short Form Health Survey (SF-12)

    The SF-12 is a 12-item, patient-reported, generic, non-disease specific, overall HRQoL instrument with extensive use in multiple disease states.

    Measured: Baseline to Week 48

  7. Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement]

    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.

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start4 Feb 2021
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

Resources

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
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04758117
Sponsor's protocol ID
P20-483
Acronym
UPJOINT
Status last verified
Jul 2024
First submitted
16 Feb 2021
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Werner SG, Schwarze I, Baraliakos X, Fiene M, Walter J, Girard T, Laliberte MC, Jeromin K, Baschuk N, Allard-Charmard H, Bessette L, Hueber AJ. Effectiveness and Safety of Upadacitinib in Treating Oligoarticular and Polyarticular Psoriatic Arthritis: Primary Analysis from the UPJOINT-Study. Rheumatol Ther. 2026 Feb;13(1):45-64. doi: 10.1007/s40744-025-00802-5. Epub 2025 Nov 5.

    PubMed 41191276

  • Werner SG, Baraliakos X, Reckert S, Bohl-Buhler M, Laliberte MC, Girard T, Jeromin K, Baschuk N, Fritz B, Bessette L, Hueber AJ. Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice. Rheumatol Ther. 2023 Dec;10(6):1503-1518. doi: 10.1007/s40744-023-00589-3. Epub 2023 Sep 11.

    PubMed 37695506

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis, run by AbbVie at 93 sites in 2 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 3 inclusion and 3 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Germany, Canada. 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 Receiving Upadacitinib who Attain Minimal Disease Activity (MDA) (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04758117, which also lists 2 linked publications.

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 17 Jul 2024.

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