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

Psoriatic Arthritis Clinical Trial

— UPJOINT  

Official title:

Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758117
• Other study ID #: P20-483
• Status: Completed
• Start date: February 4, 2021
• Est. completion date: July 26, 2023

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
Canada	The Waterside Clinic /ID# 234146	Barrie	Ontario
Canada	Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565	Dundas	Ontario
Canada	Arthur Karasik Medicine Professional Corporation /ID# 234147	Etobicoke	Ontario
Canada	Lau Bacchus Professional Medicine Corp /ID# 245283	Hamilton	Ontario
Canada	Credit Valley Rheumatology /ID# 234144	Mississauga	Ontario
Canada	Clinique de Rhumatologie de Montreal /ID# 239613	Montreal	Quebec
Canada	Applied Medical Informatics Research Inc. (AMIR) /ID# 239614	Montréal	Quebec
Canada	Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 239611	Oshawa	Ontario
Canada	Angela Montgomery Medicine Professional Corporation /ID# 239608	Ottawa	Ontario
Canada	CISSSBSL -Hopital regional de Rimouski /ID# 234150	Rimouski	Quebec
Canada	Groupe de Recherche en Maladies Osseuses Inc /ID# 234145	Sainte-foy	Quebec
Canada	Dr Naik-Medical Professional Corporation-Alliance Health /ID# 234149	Saskatoon	Saskatchewan
Canada	CIUSSS de l'Estrie - CHUS /ID# 241054	Sherbrooke	Quebec
Canada	Niagara Peninsula Arthritis Ct /ID# 245521	St. Catharines	Ontario
Canada	Centre de Recherche Musculo-Squelettique /ID# 234151	Trois-rivières	Quebec
Canada	Dr. Jonathan D. Chan Inc. /ID# 241611	Vancouver	British Columbia
Canada	Dr. Sabeen Anwar Medicine Professional Corporation /ID# 242696	Windsor	Ontario
Canada	Manitoba Clinic /ID# 234148	Winnipeg	Manitoba
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	ACURA Rheumazentrum Baden-Bade /ID# 239202	Baden-baden
Germany	Rheumapraxis Prof Dr Karin Manger /ID# 229120	Bamberg
Germany	Sozialstiftung Bamberg /ID# 228549	Bamberg
Germany	Internistische-rheumatologische Praxisgemeinschaft /ID# 228240	Bayreuth
Germany	MVZ Rheumatologie /ID# 240868	Berlin
Germany	Praxis Dr. med. Angela Seifert /ID# 233772	Berlin
Germany	Praxis Dr. Silke Zinke /ID# 229127	Berlin
Germany	Rheumapraxis am Schlachtensee /ID# 228800	Berlin
Germany	Eisterhues, Braunschweig, DE /ID# 227390	Braunschweig
Germany	Fachpraxis fuer Rheumatologie und Osteologie /ID# 227391	Bruchhausen-Vilsen	Niedersachsen
Germany	Dres. Schuh /ID# 227411	Coburg
Germany	Krankenhaus Porz am Rhein /ID# 228358	Cologne
Germany	Rheumatologie in Veedel /ID# 228469	Cologne
Germany	Praxis Dr. Kirrstetter /ID# 229609	Deggendorf
Germany	Kreiskrankenhaus Demmin /ID# 228253	Demmin
Germany	Rheumatologisches MVZ Dresden /ID# 230787	Dresden
Germany	Praxis Dilltal /ID# 228640	Ehringshausen
Germany	MVZ Ambulantes Rheumazentrum Erfurt /ID# 248933	Erfurt
Germany	Dres. Waehrisch/Flaxenberg /ID# 228263	Essen
Germany	Michael Mueller, Freiberg, DE /ID# 228468	Freiberg
Germany	Praxis Dr. Behringer /ID# 229275	Fulda
Germany	Internistisches Praxiszentrum /ID# 228262	Gießen	Hessen
Germany	Rockwitz, Goslar, DE /ID# 227856	Goslar
Germany	Praxis Fiene /ID# 244732	Greifswald
Germany	Praxis Dr. Kuehne /ID# 229119	Haldensleben
Germany	Praxis Dr. Liebhaber /ID# 228636	Halle
Germany	Stille, Hanover, DE /ID# 229604	Hannover
Germany	Heilig, Heidelberg, DE /ID# 228356	Heidelberg
Germany	St. Elisabeth Gruppe GmbH -Katholische Kliniken /ID# 228797	Herne
Germany	Praxis Bernd Mueller /ID# 230776	Homburg
Germany	Praxis K. Pagel /ID# 228247	Hoppegarten
Germany	Kremers, Juelich, DE /ID# 240383	Juelich
Germany	Rheumapraxis Kaufering /ID# 231391	Kaufering
Germany	Alb-Donau Klinikum, Langenau /ID# 233770	Langenau
Germany	Hamann & Teich & Boche,Leipzig /ID# 228355	Leipzig
Germany	Praxis internistische Rheumatologie /ID# 227857	Leipzig
Germany	Dres. Teipel/Toussaint/Saech /ID# 228465	Leverkusen
Germany	Dr. Bolze, Ludwigshafen, DE /ID# 230773	Ludwigshafen
Germany	Aurich & Sieburg, Magdeburg /ID# 229605	Magdeburg
Germany	Praxis Dr. Annekatrin Rossbach /ID# 230783	Mansfeld / Großörner
Germany	Harmuth, Marktredwitz, DE /ID# 227709	Marktredwitz
Germany	RHIO Forschungsinstitut /ID# 227736	Meerbusch
Germany	Vollmer & Partner, DE /ID# 240869	Moenchengladbach
Germany	Praxis Dres. Kellerer/Kellerer/Krüger /ID# 227414	Munich	Bayern
Germany	Prof-med-stud.de /ID# 228637	Munich
Germany	Rheumatologische Facharztpraxis /ID# 228808	Naumburg (Saale)
Germany	Berger, Naunhof, DE /ID# 229612	Naunhof
Germany	Praxis Dr. med Thilo Klopsch /ID# 229123	Neubrandenburg
Germany	Erbsloeh-Moeller, Neunkirchen /ID# 230778	Neunkirchen
Germany	MVZ Medic-Center Nürnberg GmbH /ID# 240982	Nuremberg
Germany	Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 230774	Pfarrkirchen
Germany	MVZ für Rheumatologie Dr. M. Welcker /ID# 227858	Planegg
Germany	Baumann & Lang, Plauen, DE /ID# 229128	Plauen
Germany	Praxis Dr. Sabine Reckert /ID# 248986	Potsdam
Germany	Rheumahaus Studien GbR, Potsdam, DE /ID# 230771	Potsdam	Brandenburg
Germany	Knappschaftsklinikum Saar /ID# 248882	Puettlingen
Germany	Rheumazentrum Ratingen /ID# 228261	Ratingen
Germany	Rheumatologische Praxis Dr. Jochen Walter /ID# 229607	Rendsburg
Germany	Rheumatologische Gemeinschaftspraxis Schwerin /ID# 228260	Schwerin
Germany	Melzer, Seesen, DE /ID# 227386	Seesen
Germany	Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 228805	Straubing
Germany	Krankenhaus der Barmherzigen Brueder Trier /ID# 229603	Trier
Germany	Praxis Dr. Haas /ID# 228813	Tuebingen
Germany	Praxis Dr. Rinaldi /ID# 228639	Ulm	Baden-Wuerttemberg
Germany	Rheumathologie Ulm /ID# 238801	Ulm
Germany	MVZ Lahn-Dill-Kliniken GmbH /ID# 231390	Wetzlar
Germany	MVZ Lahn-Dill-Kliniken GmbH /ID# 262011	Wetzlar
Germany	Krankenhaus St. Josef /ID# 229611	Wuppertal
Germany	Praxis Barmen /ID# 227392	Wuppertal
Germany	Sprekeler, Zeven, DE /ID# 233773	Zeven
Germany	Fricke-Wagner, Zwickau, DE /ID# 230775	Zwickau

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At Week 48
Secondary	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).	Baseline to Week 48
Secondary	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.	Baseline to Week 48
Secondary	Mean Change in Percentage of Participants with Dactylitis	Mean change in percentage of participants with dactylitis.	Baseline to Week 48
Secondary	Mean Change in Number of Fingernails Affected with Psoriasis	Mean change in number of fingernails affected with psoriasis.	Baseline to Week 48
Secondary	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.	Baseline to Week 48
Secondary	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.	Baseline to Week 48

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.