Clinical trial NCT04758117: 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
Official title: Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Oligoarticular Psoriatic Arthritis
Polyarticular Psoriatic Arthritis
Upadacitinib
Rinvoq
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with psoriatic arthritis (PsA).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)
timeFrame: At Week 24
Secondary outcomes:
measure: Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24
timeFrame: At Week 48
measure: Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip)
timeFrame: Baseline to Week 48
measure: Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA)
timeFrame: Baseline to Week 48
measure: Mean Change in Percentage of Participants with Dactylitis
timeFrame: Baseline to Week 48
measure: Mean Change in Number of Fingernails Affected with Psoriasis
timeFrame: Baseline to Week 48
measure: Mean Change in 12-Item Short Form Health Survey (SF-12)
timeFrame: Baseline to Week 48
measure: Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement]
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr. Jonathan D. Chan Inc. /ID# 241611
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 234148
state: Manitoba
city: Barrie
country: Canada
facility: The Waterside Clinic /ID# 234146
state: Ontario
city: Dundas
country: Canada
facility: Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565
state: Ontario
city: Etobicoke
country: Canada
facility: Arthur Karasik Medicine Professional Corporation /ID# 234147
state: Ontario
city: Hamilton
country: Canada
facility: Lau Bacchus Professional Medicine Corp /ID# 245283
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 234144
state: Ontario
city: Oshawa
country: Canada
facility: Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 239611
state: Ontario
city: Ottawa
country: Canada
facility: Angela Montgomery Medicine Professional Corporation /ID# 239608
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Ct /ID# 245521
state: Ontario
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696
state: Ontario
city: Montreal
country: Canada
facility: Clinique de Rhumatologie de Montreal /ID# 239613
state: Quebec
city: Montréal
country: Canada
facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 239614
state: Quebec
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 234150
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 234145
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 241054
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 234151
state: Quebec
city: Saskatoon
country: Canada
facility: Dr Naik-Medical Professional Corporation-Alliance Health /ID# 234149
state: Saskatchewan
city: Ulm
country: Germany
facility: Praxis Dr. Rinaldi /ID# 228639
state: Baden-Wuerttemberg
city: Munich
country: Germany
facility: Praxis Dres. Kellerer/Kellerer/Krüger /ID# 227414
state: Bayern
city: Potsdam
country: Germany
facility: Rheumahaus Studien GbR, Potsdam, DE /ID# 230771
state: Brandenburg
city: Gießen
country: Germany
facility: Internistisches Praxiszentrum /ID# 228262
state: Hessen
city: Bruchhausen-Vilsen
country: Germany
facility: Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391
state: Niedersachsen
city: Altenburg
country: Germany
facility: Kupka & Kupka, Altenburg, DE /ID# 228243
city: Amberg
country: Germany
facility: Marycz, Amberg, DE /ID# 227413
city: Augsburg
country: Germany
facility: Rheumapraxis am Webereck /ID# 229274
city: Bad Pyrmont
country: Germany
facility: MVZ Weserbergland /ID# 228806
city: Baden-baden
country: Germany
facility: ACURA Rheumazentrum Baden-Bade /ID# 239202
city: Bamberg
country: Germany
facility: Rheumapraxis Prof Dr Karin Manger /ID# 229120
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg /ID# 228549
city: Bayreuth
country: Germany
facility: Internistische-rheumatologische Praxisgemeinschaft /ID# 228240
city: Berlin
country: Germany
facility: MVZ Rheumatologie /ID# 240868
city: Berlin
country: Germany
facility: Praxis Dr. med. Angela Seifert /ID# 233772
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke /ID# 229127
city: Berlin
country: Germany
facility: Rheumapraxis am Schlachtensee /ID# 228800
city: Braunschweig
country: Germany
facility: Eisterhues, Braunschweig, DE /ID# 227390
city: Coburg
country: Germany
facility: Dres. Schuh /ID# 227411
city: Cologne
country: Germany
facility: Rheumatologie in Veedel /ID# 228469
city: Cologne
country: Germany
facility: Krankenhaus Porz am Rhein /ID# 228358
city: Deggendorf
country: Germany
facility: Praxis Dr. Kirrstetter /ID# 229609
city: Demmin
country: Germany
facility: Kreiskrankenhaus Demmin /ID# 228253
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden /ID# 230787
city: Ehringshausen
country: Germany
facility: Praxis Dilltal /ID# 228640
city: Erfurt
country: Germany
facility: MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933
city: Essen
country: Germany
facility: Dres. Waehrisch/Flaxenberg /ID# 228263
city: Freiberg
country: Germany
facility: Michael Mueller, Freiberg, DE /ID# 228468
city: Fulda
country: Germany
facility: Praxis Dr. Behringer /ID# 229275
city: Goslar
country: Germany
facility: Rockwitz, Goslar, DE /ID# 227856
city: Greifswald
country: Germany
facility: Praxis Fiene /ID# 244732
city: Haldensleben
country: Germany
facility: Praxis Dr. Kuehne /ID# 229119
city: Halle
country: Germany
facility: Praxis Dr. Liebhaber /ID# 228636
city: Hannover
country: Germany
facility: Stille, Hanover, DE /ID# 229604
city: Heidelberg
country: Germany
facility: Heilig, Heidelberg, DE /ID# 228356
city: Herne
country: Germany
facility: St. Elisabeth Gruppe GmbH -Katholische Kliniken /ID# 228797
city: Homburg
country: Germany
facility: Praxis Bernd Mueller /ID# 230776
city: Hoppegarten
country: Germany
facility: Praxis K. Pagel /ID# 228247
city: Juelich
country: Germany
facility: Kremers, Juelich, DE /ID# 240383
city: Kaufering
country: Germany
facility: Rheumapraxis Kaufering /ID# 231391
city: Langenau
country: Germany
facility: Alb-Donau Klinikum, Langenau /ID# 233770
city: Leipzig
country: Germany
facility: Hamann & Teich & Boche,Leipzig /ID# 228355
city: Leipzig
country: Germany
facility: Praxis internistische Rheumatologie /ID# 227857
city: Leverkusen
country: Germany
facility: Dres. Teipel/Toussaint/Saech /ID# 228465
city: Ludwigshafen
country: Germany
facility: Dr. Bolze, Ludwigshafen, DE /ID# 230773
city: Magdeburg
country: Germany
facility: Aurich & Sieburg, Magdeburg /ID# 229605
city: Mansfeld / Großörner
country: Germany
facility: Praxis Dr. Annekatrin Rossbach /ID# 230783
city: Marktredwitz
country: Germany
facility: Harmuth, Marktredwitz, DE /ID# 227709
city: Meerbusch
country: Germany
facility: RHIO Forschungsinstitut /ID# 227736
city: Moenchengladbach
country: Germany
facility: Vollmer & Partner, DE /ID# 240869
city: Munich
country: Germany
facility: Prof-med-stud.de /ID# 228637
city: Naumburg (Saale)
country: Germany
facility: Rheumatologische Facharztpraxis /ID# 228808
city: Naunhof
country: Germany
facility: Berger, Naunhof, DE /ID# 229612
city: Neubrandenburg
country: Germany
facility: Praxis Dr. med Thilo Klopsch /ID# 229123
city: Neunkirchen
country: Germany
facility: Erbsloeh-Moeller, Neunkirchen /ID# 230778
city: Nuremberg
country: Germany
facility: MVZ Medic-Center Nürnberg GmbH /ID# 240982
city: Pfarrkirchen
country: Germany
facility: Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 230774
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. M. Welcker /ID# 227858
city: Plauen
country: Germany
facility: Baumann & Lang, Plauen, DE /ID# 229128
city: Potsdam
country: Germany
facility: Praxis Dr. Sabine Reckert /ID# 248986
city: Puettlingen
country: Germany
facility: Knappschaftsklinikum Saar /ID# 248882
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen /ID# 228261
city: Rendsburg
country: Germany
facility: Rheumatologische Praxis Dr. Jochen Walter /ID# 229607
city: Schwerin
country: Germany
facility: Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260
city: Seesen
country: Germany
facility: Melzer, Seesen, DE /ID# 227386
city: Straubing
country: Germany
facility: Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brueder Trier /ID# 229603
city: Tuebingen
country: Germany
facility: Praxis Dr. Haas /ID# 228813
city: Ulm
country: Germany
facility: Rheumathologie Ulm /ID# 238801
city: Wetzlar
country: Germany
facility: MVZ Lahn-Dill-Kliniken GmbH /ID# 231390
city: Wetzlar
country: Germany
facility: MVZ Lahn-Dill-Kliniken GmbH /ID# 262011
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef /ID# 229611
city: Wuppertal
country: Germany
facility: Praxis Barmen /ID# 227392
city: Zeven
country: Germany
facility: Sprekeler, Zeven, DE /ID# 233773
city: Zwickau
country: Germany
facility: Fricke-Wagner, Zwickau, DE /ID# 230775
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: