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

NCT04758117 | Completed

• 1 other identifier: P20-483
• Study Type: observational
• Target: 394
• Locations: 2 countries
• Sites: 93

Brief 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 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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; Oligoarticular Psoriatic Arthritis; Polyarticular Psoriatic Arthritis; Upadacitinib; Rinvoq

Outcome Measures

Primary Outcomes (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.

  At Week 24

Secondary Outcomes (7)

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

  At Week 48

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

  Baseline to Week 48

• Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA)

  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

  Baseline to Week 48

Study Arms (1)

Participants Receiving Upadacitinib

Participants receiving Upadacitinib for psoriatic arthritis (PsA).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with psoriatic arthritis (PsA).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (93)

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

Vancouver, British Columbia, V5Z 1J9, Canada

Location

Manitoba Clinic /ID# 234148

Winnipeg, Manitoba, R3A 1M3, Canada

Location

The Waterside Clinic /ID# 234146

Barrie, Ontario, L4M 6L2, Canada

Location

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

Dundas, Ontario, L9H 1B7, Canada

Location

Arthur Karasik Medicine Professional Corporation /ID# 234147

Etobicoke, Ontario, M9C 5N2, Canada

Location

Lau Bacchus Professional Medicine Corp /ID# 245283

Hamilton, Ontario, L8N 1Y2, Canada

Location

Credit Valley Rheumatology /ID# 234144

Mississauga, Ontario, L5M 2V8, Canada

Location

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

Oshawa, Ontario, L1H 1B9, Canada

Location

Angela Montgomery Medicine Professional Corporation /ID# 239608

Ottawa, Ontario, K1H 7X3, Canada

Location

Niagara Peninsula Arthritis Ct /ID# 245521

St. Catharines, Ontario, L2N 7E4, Canada

Location

Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696

Windsor, Ontario, N8X 1T3, Canada

Location

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

Montreal, Quebec, H4A 3T2, Canada

Location

Clinique de Rhumatologie de Montreal /ID# 239613

Montreal, Quebec, H4N 1C6, Canada

Location

CISSSBSL -Hopital regional de Rimouski /ID# 234150

Rimouski, Quebec, G5L 5T1, Canada

Location

Groupe de Recherche en Maladies Osseuses Inc /ID# 234145

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

CIUSSS de l'Estrie - CHUS /ID# 241054

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Centre de Recherche Musculo-Squelettique /ID# 234151

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

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

Saskatoon, Saskatchewan, S7H 5M7, Canada

Location

Praxis Dr. Rinaldi /ID# 228639

Ulm, Baden-Wurttemberg, 89073, Germany

Location

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

Munich, Bavaria, 81541, Germany

Location

Rheumahaus Studien GbR, Potsdam, DE /ID# 230771

Potsdam, Brandenburg, 14467, Germany

Location

Internistisches Praxiszentrum /ID# 228262

Giessen, Hesse, 35392, Germany

Location

Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391

Bruchhausen-Vilsen, Lower Saxony, 27305, Germany

Location

Kupka & Kupka, Altenburg, DE /ID# 228243

Altenburg, 04600, Germany

Location

Marycz, Amberg, DE /ID# 227413

Amberg, 92224, Germany

Location

Rheumapraxis am Webereck /ID# 229274

Augsburg, 86157, Germany

Location

MVZ Weserbergland /ID# 228806

Bad Pyrmont, 31812, Germany

Location

ACURA Rheumazentrum Baden-Bade /ID# 239202

Baden-Baden, 76530, Germany

Location

Rheumapraxis Prof Dr Karin Manger /ID# 229120

Bamberg, 96047, Germany

Location

Sozialstiftung Bamberg /ID# 228549

Bamberg, 96049, Germany

Location

Internistische-rheumatologische Praxisgemeinschaft /ID# 228240

Bayreuth, 95444, Germany

Location

MVZ Rheumatologie /ID# 240868

Berlin, 10117, Germany

Location

Praxis Dr. med. Angela Seifert /ID# 233772

Berlin, 12555, Germany

Location

Praxis Dr. Silke Zinke /ID# 229127

Berlin, 13055, Germany

Location

Rheumapraxis am Schlachtensee /ID# 228800

Berlin, 14129, Germany

Location

Eisterhues, Braunschweig, DE /ID# 227390

Braunschweig, 38100, Germany

Location

Dres. Schuh /ID# 227411

Coburg, 96450, Germany

Location

Rheumatologie in Veedel /ID# 228469

Cologne, 50825, Germany

Location

Krankenhaus Porz am Rhein /ID# 228358

Cologne, 51149, Germany

Location

Praxis Dr. Kirrstetter /ID# 229609

Deggendorf, 94469, Germany

Location

Kreiskrankenhaus Demmin /ID# 228253

Demmin, 17109, Germany

Location

Rheumatologisches MVZ Dresden /ID# 230787

Dresden, 01109, Germany

Location

Praxis Dilltal /ID# 228640

Ehringshausen, 35630, Germany

Location

MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933

Erfurt, 99096, Germany

Location

Dres. Waehrisch/Flaxenberg /ID# 228263

Essen, 45326, Germany

Location

Michael Mueller, Freiberg, DE /ID# 228468

Freiberg, 09599, Germany

Location

Praxis Dr. Behringer /ID# 229275

Fulda, 36039, Germany

Location

Rockwitz, Goslar, DE /ID# 227856

Goslar, 38642, Germany

Location

Praxis Fiene /ID# 244732

Greifswald, 17493, Germany

Location

Praxis Dr. Kuehne /ID# 229119

Haldensleben I, 39340, Germany

Location

Praxis Dr. Liebhaber /ID# 228636

Halle, 06128, Germany

Location

Stille, Hanover, DE /ID# 229604

Hanover, 30161, Germany

Location

Heilig, Heidelberg, DE /ID# 228356

Heidelberg, 69120, Germany

Location

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

Herne, 44649, Germany

Location

Praxis Bernd Mueller /ID# 230776

Homburg, 66424, Germany

Location

Praxis K. Pagel /ID# 228247

Hoppegarten, 15366, Germany

Location

Kremers, Juelich, DE /ID# 240383

Jülich, 52428, Germany

Location

Rheumapraxis Kaufering /ID# 231391

Kaufering, 86916, Germany

Location

Alb-Donau Klinikum, Langenau /ID# 233770

Langenau, 89129, Germany

Location

Hamann & Teich & Boche,Leipzig /ID# 228355

Leipzig, 04109, Germany

Location

Praxis internistische Rheumatologie /ID# 227857

Leipzig, 04129, Germany

Location

Dres. Teipel/Toussaint/Saech /ID# 228465

Leverkusen, 51373, Germany

Location

Dr. Bolze, Ludwigshafen, DE /ID# 230773

Ludwigshafen, 67069, Germany

Location

Aurich & Sieburg, Magdeburg /ID# 229605

Magdeburg, 39104, Germany

Location

Praxis Dr. Annekatrin Rossbach /ID# 230783

Mansfeld / Großörner, 06343, Germany

Location

Harmuth, Marktredwitz, DE /ID# 227709

Marktredwitz, 95615, Germany

Location

RHIO Forschungsinstitut /ID# 227736

Meerbusch, 40668, Germany

Location

Vollmer & Partner, DE /ID# 240869

Mönchengladbach, 41061, Germany

Location

Prof-med-stud.de /ID# 228637

Munich, 80935, Germany

Location

Rheumatologische Facharztpraxis /ID# 228808

Naumburg, 06618, Germany

Location

Berger, Naunhof, DE /ID# 229612

Naunhof, 04683, Germany

Location

Praxis Dr. med Thilo Klopsch /ID# 229123

Neubrandenburg, 17033, Germany

Location

Erbsloeh-Moeller, Neunkirchen /ID# 230778

Neunkirchen, 66538, Germany

Location

MVZ Medic-Center Nürnberg GmbH /ID# 240982

Nuremberg, 90443, Germany

Location

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

Pfarrkirchen, 84347, Germany

Location

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

Planegg, 82152, Germany

Location

Baumann & Lang, Plauen, DE /ID# 229128

Plauen, 08523, Germany

Location

Praxis Dr. Sabine Reckert /ID# 248986

Potsdam, 14469, Germany

Location

Knappschaftsklinikum Saar /ID# 248882

Püttlingen, 66346, Germany

Location

Rheumazentrum Ratingen /ID# 228261

Ratingen, 40882, Germany

Location

Rheumatologische Praxis Dr. Jochen Walter /ID# 229607

Rendsburg, 24768, Germany

Location

Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260

Schwerin, 19053, Germany

Location

Melzer, Seesen, DE /ID# 227386

Seesen, 38723, Germany

Location

Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805

Straubing, 94315, Germany

Location

Krankenhaus der Barmherzigen Brueder Trier /ID# 229603

Trier, 54292, Germany

Location

Praxis Dr. Haas /ID# 228813

Tübingen, 72072, Germany

Location

Rheumathologie Ulm /ID# 238801

Ulm, 89073, Germany

Location

MVZ Lahn-Dill-Kliniken GmbH /ID# 231390

Wetzlar, 35578, Germany

Location

MVZ Lahn-Dill-Kliniken GmbH /ID# 262011

Wetzlar, 35578, Germany

Location

Krankenhaus St. Josef /ID# 229611

Wuppertal, 42105, Germany

Location

Praxis Barmen /ID# 227392

Wuppertal, 42285, Germany

Location

Sprekeler, Zeven, DE /ID# 233773

Zeven, 27404, Germany

Location

Fricke-Wagner, Zwickau, DE /ID# 230775

Zwickau, 08060, Germany

Location

Related Publications (2)

• 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.

  PMID: 41191276 DERIVED

• 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.

  PMID: 37695506 DERIVED

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 17, 2021
• Study Start: February 4, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

DE (75); CA (18)