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
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT04758117
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 394
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24 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.
Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA) 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.
Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement] 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.
Mean Change in 12-Item Short Form Health Survey (SF-12) 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.
Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip) 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).
Mean Change in Percentage of Participants with Dactylitis Baseline to Week 48 Mean change in percentage of participants with dactylitis.
Mean Change in Number of Fingernails Affected with Psoriasis Baseline to Week 48 Mean change in number of fingernails affected with psoriasis.
Trial Locations
- Locations (93)
Dr. Jonathan D. Chan Inc. /ID# 241611
🇨🇦Vancouver, British Columbia, Canada
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 234149
🇨🇦Saskatoon, Saskatchewan, Canada
Rheumahaus Studien GbR, Potsdam, DE /ID# 230771
🇩🇪Potsdam, Brandenburg, Germany
The Waterside Clinic /ID# 234146
🇨🇦Barrie, Ontario, Canada
Manitoba Clinic /ID# 234148
🇨🇦Winnipeg, Manitoba, Canada
Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 239611
🇨🇦Oshawa, Ontario, Canada
Hamann & Teich & Boche,Leipzig /ID# 228355
🇩🇪Leipzig, Germany
Baumann & Lang, Plauen, DE /ID# 229128
🇩🇪Plauen, Germany
Knappschaftsklinikum Saar /ID# 248882
🇩🇪Puettlingen, Germany
Fricke-Wagner, Zwickau, DE /ID# 230775
🇩🇪Zwickau, Germany
Rheumatologie in Veedel /ID# 228469
🇩🇪Cologne, Germany
Sozialstiftung Bamberg /ID# 228549
🇩🇪Bamberg, Germany
Dres. Schuh /ID# 227411
🇩🇪Coburg, Germany
Internistische-rheumatologische Praxisgemeinschaft /ID# 228240
🇩🇪Bayreuth, Germany
Rheumapraxis am Schlachtensee /ID# 228800
🇩🇪Berlin, Germany
MVZ Rheumatologie /ID# 240868
🇩🇪Berlin, Germany
Praxis Dr. med. Angela Seifert /ID# 233772
🇩🇪Berlin, Germany
Praxis Dr. Kirrstetter /ID# 229609
🇩🇪Deggendorf, Germany
Dres. Waehrisch/Flaxenberg /ID# 228263
🇩🇪Essen, Germany
Michael Mueller, Freiberg, DE /ID# 228468
🇩🇪Freiberg, Germany
Krankenhaus Porz am Rhein /ID# 228358
🇩🇪Cologne, Germany
Kreiskrankenhaus Demmin /ID# 228253
🇩🇪Demmin, Germany
Praxis Dr. Behringer /ID# 229275
🇩🇪Fulda, Germany
Kremers, Juelich, DE /ID# 240383
🇩🇪Juelich, Germany
Heilig, Heidelberg, DE /ID# 228356
🇩🇪Heidelberg, Germany
Krankenhaus der Barmherzigen Brueder Trier /ID# 229603
🇩🇪Trier, Germany
Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565
🇨🇦Dundas, Ontario, Canada
Credit Valley Rheumatology /ID# 234144
🇨🇦Mississauga, Ontario, Canada
Arthur Karasik Medicine Professional Corporation /ID# 234147
🇨🇦Etobicoke, Ontario, Canada
Angela Montgomery Medicine Professional Corporation /ID# 239608
🇨🇦Ottawa, Ontario, Canada
Lau Bacchus Professional Medicine Corp /ID# 245283
🇨🇦Hamilton, Ontario, Canada
Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696
🇨🇦Windsor, Ontario, Canada
Clinique de Rhumatologie de Montreal /ID# 239613
🇨🇦Montreal, Quebec, Canada
Niagara Peninsula Arthritis Ct /ID# 245521
🇨🇦St. Catharines, Ontario, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 234145
🇨🇦Sainte-foy, Quebec, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 234150
🇨🇦Rimouski, Quebec, Canada
Centre de Recherche Musculo-Squelettique /ID# 234151
🇨🇦Trois-rivières, Quebec, Canada
Applied Medical Informatics Research Inc. (AMIR) /ID# 239614
🇨🇦Montréal, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 241054
🇨🇦Sherbrooke, Quebec, Canada
Praxis Dres. Kellerer/Kellerer/Krüger /ID# 227414
🇩🇪Munich, Bayern, Germany
Praxis Dr. Rinaldi /ID# 228639
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Internistisches Praxiszentrum /ID# 228262
🇩🇪Gießen, Hessen, Germany
Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391
🇩🇪Bruchhausen-Vilsen, Niedersachsen, Germany
Kupka & Kupka, Altenburg, DE /ID# 228243
🇩🇪Altenburg, Germany
Marycz, Amberg, DE /ID# 227413
🇩🇪Amberg, Germany
Rheumapraxis am Webereck /ID# 229274
🇩🇪Augsburg, Germany
MVZ Weserbergland /ID# 228806
🇩🇪Bad Pyrmont, Germany
Rheumapraxis Prof Dr Karin Manger /ID# 229120
🇩🇪Bamberg, Germany
ACURA Rheumazentrum Baden-Bade /ID# 239202
🇩🇪Baden-baden, Germany
Praxis Dr. Silke Zinke /ID# 229127
🇩🇪Berlin, Germany
Eisterhues, Braunschweig, DE /ID# 227390
🇩🇪Braunschweig, Germany
Rheumatologisches MVZ Dresden /ID# 230787
🇩🇪Dresden, Germany
MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933
🇩🇪Erfurt, Germany
Praxis Dilltal /ID# 228640
🇩🇪Ehringshausen, Germany
Praxis Dr. Kuehne /ID# 229119
🇩🇪Haldensleben, Germany
Rockwitz, Goslar, DE /ID# 227856
🇩🇪Goslar, Germany
Praxis Fiene /ID# 244732
🇩🇪Greifswald, Germany
Stille, Hanover, DE /ID# 229604
🇩🇪Hannover, Germany
St. Elisabeth Gruppe GmbH -Katholische Kliniken /ID# 228797
🇩🇪Herne, Germany
Praxis Dr. Liebhaber /ID# 228636
🇩🇪Halle, Germany
Praxis K. Pagel /ID# 228247
🇩🇪Hoppegarten, Germany
Praxis Bernd Mueller /ID# 230776
🇩🇪Homburg, Germany
Alb-Donau Klinikum, Langenau /ID# 233770
🇩🇪Langenau, Germany
Rheumapraxis Kaufering /ID# 231391
🇩🇪Kaufering, Germany
Praxis Dr. Annekatrin Rossbach /ID# 230783
🇩🇪Mansfeld / Großörner, Germany
Dres. Teipel/Toussaint/Saech /ID# 228465
🇩🇪Leverkusen, Germany
RHIO Forschungsinstitut /ID# 227736
🇩🇪Meerbusch, Germany
Praxis internistische Rheumatologie /ID# 227857
🇩🇪Leipzig, Germany
Dr. Bolze, Ludwigshafen, DE /ID# 230773
🇩🇪Ludwigshafen, Germany
Aurich & Sieburg, Magdeburg /ID# 229605
🇩🇪Magdeburg, Germany
Harmuth, Marktredwitz, DE /ID# 227709
🇩🇪Marktredwitz, Germany
Vollmer & Partner, DE /ID# 240869
🇩🇪Moenchengladbach, Germany
Prof-med-stud.de /ID# 228637
🇩🇪Munich, Germany
Erbsloeh-Moeller, Neunkirchen /ID# 230778
🇩🇪Neunkirchen, Germany
Rheumatologische Facharztpraxis /ID# 228808
🇩🇪Naumburg (Saale), Germany
Praxis Dr. med Thilo Klopsch /ID# 229123
🇩🇪Neubrandenburg, Germany
MVZ Medic-Center Nürnberg GmbH /ID# 240982
🇩🇪Nuremberg, Germany
Berger, Naunhof, DE /ID# 229612
🇩🇪Naunhof, Germany
MVZ für Rheumatologie Dr. M. Welcker /ID# 227858
🇩🇪Planegg, Germany
Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 230774
🇩🇪Pfarrkirchen, Germany
Praxis Dr. Sabine Reckert /ID# 248986
🇩🇪Potsdam, Germany
Rheumazentrum Ratingen /ID# 228261
🇩🇪Ratingen, Germany
Rheumatologische Praxis Dr. Jochen Walter /ID# 229607
🇩🇪Rendsburg, Germany
Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260
🇩🇪Schwerin, Germany
Praxis Dr. Haas /ID# 228813
🇩🇪Tuebingen, Germany
Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805
🇩🇪Straubing, Germany
Melzer, Seesen, DE /ID# 227386
🇩🇪Seesen, Germany
Rheumathologie Ulm /ID# 238801
🇩🇪Ulm, Germany
MVZ Lahn-Dill-Kliniken GmbH /ID# 262011
🇩🇪Wetzlar, Germany
MVZ Lahn-Dill-Kliniken GmbH /ID# 231390
🇩🇪Wetzlar, Germany
Krankenhaus St. Josef /ID# 229611
🇩🇪Wuppertal, Germany
Sprekeler, Zeven, DE /ID# 233773
🇩🇪Zeven, Germany
Praxis Barmen /ID# 227392
🇩🇪Wuppertal, Germany