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

NCT ID: NCT04758117

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2023-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Receiving Upadacitinib

Participants receiving Upadacitinib for psoriatic arthritis (PsA).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Vancouver, British Columbia, Canada

Site Status

Manitoba Clinic /ID# 234148

Winnipeg, Manitoba, Canada

Site Status

The Waterside Clinic /ID# 234146

Barrie, Ontario, Canada

Site Status

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

Dundas, Ontario, Canada

Site Status

Arthur Karasik Medicine Professional Corporation /ID# 234147

Etobicoke, Ontario, Canada

Site Status

Lau Bacchus Professional Medicine Corp /ID# 245283

Hamilton, Ontario, Canada

Site Status

Credit Valley Rheumatology /ID# 234144

Mississauga, Ontario, Canada

Site Status

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

Oshawa, Ontario, Canada

Site Status

Angela Montgomery Medicine Professional Corporation /ID# 239608

Ottawa, Ontario, Canada

Site Status

Niagara Peninsula Arthritis Ct /ID# 245521

St. Catharines, Ontario, Canada

Site Status

Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696

Windsor, Ontario, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

Clinique de Rhumatologie de Montreal /ID# 239613

Montreal, Quebec, Canada

Site Status

CISSSBSL -Hopital regional de Rimouski /ID# 234150

Rimouski, Quebec, Canada

Site Status

Groupe de Recherche en Maladies Osseuses Inc /ID# 234145

Sainte-Foy, Quebec, Canada

Site Status

CIUSSS de l'Estrie - CHUS /ID# 241054

Sherbrooke, Quebec, Canada

Site Status

Centre de Recherche Musculo-Squelettique /ID# 234151

Trois-Rivières, Quebec, Canada

Site Status

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

Saskatoon, Saskatchewan, Canada

Site Status

Praxis Dr. Rinaldi /ID# 228639

Ulm, Baden-Wurttemberg, Germany

Site Status

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

Munich, Bavaria, Germany

Site Status

Rheumahaus Studien GbR, Potsdam, DE /ID# 230771

Potsdam, Brandenburg, Germany

Site Status

Internistisches Praxiszentrum /ID# 228262

Giessen, Hesse, Germany

Site Status

Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391

Bruchhausen-Vilsen, Lower Saxony, Germany

Site Status

Kupka & Kupka, Altenburg, DE /ID# 228243

Altenburg, , Germany

Site Status

Marycz, Amberg, DE /ID# 227413

Amberg, , Germany

Site Status

Rheumapraxis am Webereck /ID# 229274

Augsburg, , Germany

Site Status

MVZ Weserbergland /ID# 228806

Bad Pyrmont, , Germany

Site Status

ACURA Rheumazentrum Baden-Bade /ID# 239202

Baden-Baden, , Germany

Site Status

Rheumapraxis Prof Dr Karin Manger /ID# 229120

Bamberg, , Germany

Site Status

Sozialstiftung Bamberg /ID# 228549

Bamberg, , Germany

Site Status

Internistische-rheumatologische Praxisgemeinschaft /ID# 228240

Bayreuth, , Germany

Site Status

MVZ Rheumatologie /ID# 240868

Berlin, , Germany

Site Status

Praxis Dr. med. Angela Seifert /ID# 233772

Berlin, , Germany

Site Status

Praxis Dr. Silke Zinke /ID# 229127

Berlin, , Germany

Site Status

Rheumapraxis am Schlachtensee /ID# 228800

Berlin, , Germany

Site Status

Eisterhues, Braunschweig, DE /ID# 227390

Braunschweig, , Germany

Site Status

Dres. Schuh /ID# 227411

Coburg, , Germany

Site Status

Rheumatologie in Veedel /ID# 228469

Cologne, , Germany

Site Status

Krankenhaus Porz am Rhein /ID# 228358

Cologne, , Germany

Site Status

Praxis Dr. Kirrstetter /ID# 229609

Deggendorf, , Germany

Site Status

Kreiskrankenhaus Demmin /ID# 228253

Demmin, , Germany

Site Status

Rheumatologisches MVZ Dresden /ID# 230787

Dresden, , Germany

Site Status

Praxis Dilltal /ID# 228640

Ehringshausen, , Germany

Site Status

MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933

Erfurt, , Germany

Site Status

Dres. Waehrisch/Flaxenberg /ID# 228263

Essen, , Germany

Site Status

Michael Mueller, Freiberg, DE /ID# 228468

Freiberg, , Germany

Site Status

Praxis Dr. Behringer /ID# 229275

Fulda, , Germany

Site Status

Rockwitz, Goslar, DE /ID# 227856

Goslar, , Germany

Site Status

Praxis Fiene /ID# 244732

Greifswald, , Germany

Site Status

Praxis Dr. Kuehne /ID# 229119

Haldensleben I, , Germany

Site Status

Praxis Dr. Liebhaber /ID# 228636

Halle, , Germany

Site Status

Stille, Hanover, DE /ID# 229604

Hanover, , Germany

Site Status

Heilig, Heidelberg, DE /ID# 228356

Heidelberg, , Germany

Site Status

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

Herne, , Germany

Site Status

Praxis Bernd Mueller /ID# 230776

Homburg, , Germany

Site Status

Praxis K. Pagel /ID# 228247

Hoppegarten, , Germany

Site Status

Kremers, Juelich, DE /ID# 240383

Jülich, , Germany

Site Status

Rheumapraxis Kaufering /ID# 231391

Kaufering, , Germany

Site Status

Alb-Donau Klinikum, Langenau /ID# 233770

Langenau, , Germany

Site Status

Hamann & Teich & Boche,Leipzig /ID# 228355

Leipzig, , Germany

Site Status

Praxis internistische Rheumatologie /ID# 227857

Leipzig, , Germany

Site Status

Dres. Teipel/Toussaint/Saech /ID# 228465

Leverkusen, , Germany

Site Status

Dr. Bolze, Ludwigshafen, DE /ID# 230773

Ludwigshafen, , Germany

Site Status

Aurich & Sieburg, Magdeburg /ID# 229605

Magdeburg, , Germany

Site Status

Praxis Dr. Annekatrin Rossbach /ID# 230783

Mansfeld / Großörner, , Germany

Site Status

Harmuth, Marktredwitz, DE /ID# 227709

Marktredwitz, , Germany

Site Status

RHIO Forschungsinstitut /ID# 227736

Meerbusch, , Germany

Site Status

Vollmer & Partner, DE /ID# 240869

Mönchengladbach, , Germany

Site Status

Prof-med-stud.de /ID# 228637

Munich, , Germany

Site Status

Rheumatologische Facharztpraxis /ID# 228808

Naumburg, , Germany

Site Status

Berger, Naunhof, DE /ID# 229612

Naunhof, , Germany

Site Status

Praxis Dr. med Thilo Klopsch /ID# 229123

Neubrandenburg, , Germany

Site Status

Erbsloeh-Moeller, Neunkirchen /ID# 230778

Neunkirchen, , Germany

Site Status

MVZ Medic-Center Nürnberg GmbH /ID# 240982

Nuremberg, , Germany

Site Status

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

Pfarrkirchen, , Germany

Site Status

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

Planegg, , Germany

Site Status

Baumann & Lang, Plauen, DE /ID# 229128

Plauen, , Germany

Site Status

Praxis Dr. Sabine Reckert /ID# 248986

Potsdam, , Germany

Site Status

Knappschaftsklinikum Saar /ID# 248882

Püttlingen, , Germany

Site Status

Rheumazentrum Ratingen /ID# 228261

Ratingen, , Germany

Site Status

Rheumatologische Praxis Dr. Jochen Walter /ID# 229607

Rendsburg, , Germany

Site Status

Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260

Schwerin, , Germany

Site Status

Melzer, Seesen, DE /ID# 227386

Seesen, , Germany

Site Status

Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805

Straubing, , Germany

Site Status

Krankenhaus der Barmherzigen Brueder Trier /ID# 229603

Trier, , Germany

Site Status

Praxis Dr. Haas /ID# 228813

Tübingen, , Germany

Site Status

Rheumathologie Ulm /ID# 238801

Ulm, , Germany

Site Status

MVZ Lahn-Dill-Kliniken GmbH /ID# 231390

Wetzlar, , Germany

Site Status

MVZ Lahn-Dill-Kliniken GmbH /ID# 262011

Wetzlar, , Germany

Site Status

Krankenhaus St. Josef /ID# 229611

Wuppertal, , Germany

Site Status

Praxis Barmen /ID# 227392

Wuppertal, , Germany

Site Status

Sprekeler, Zeven, DE /ID# 233773

Zeven, , Germany

Site Status

Fricke-Wagner, Zwickau, DE /ID# 230775

Zwickau, , Germany

Site Status

Countries

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Canada Germany

References

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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.

Reference Type DERIVED
PMID: 37695506 (View on PubMed)

Related Links

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Other Identifiers

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P20-483

Identifier Type: -

Identifier Source: org_study_id

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