UPtimum-PsA: An Observational Study to Assess Change in Disease Activity and Treatment Patterns of Upadacitinib When Given Alone or Co-Administered With Methotrexate in Adult Participants With Active Psoriatic Arthritis

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05616871

Collaborator

(none)

450

Enrollment

Locations

Anticipated Duration (Months)

13.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis.

Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis

Study Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Jun 14, 2026

Anticipated Study Completion Date :

Jun 14, 2026

Arms and Interventions

Arm	Intervention/Treatment
Upadacitinib Alone or In Combination with Methotrexate Participants will receive upadacitinib alone or in combination with methotrexate as prescribed by their physician according to local label in real- world practice.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14 [Month 6]
Disease Activity in Psoriatic Arthritis (DAPSA) score is calculated by the sum of values of rheumatic parameters [tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of active psoriatic arthritis (PsA) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician.
Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
Participants able to understand and communicate with the investigator and comply with the requirements of the study.

Exclusion Criteria:

Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
Prior treatment with upadacitinib.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Toulouse - Hopital Purpan /ID# 252077	TOULOUSE Cedex 9	Haute-Garonne	France	31059
2	CHU Montpellier - Hôpital Saint Eloi /ID# 252078	Montpellier Cedex 5	Herault	France	34295
3	Infirmerie Protestante /ID# 252075	Caluire Et Cuire	Rhone	France	69300
4	Hopital Henri Mondor /ID# 245194	Creteil		France	94000
5	251 Airforce General Hospital /ID# 248092	Athens	Attiki	Greece	11525
6	Henry Dunnant Hospital Center /ID# 247640	Athens	Attiki	Greece	11526
7	General Hospital of Athens Gennimatas /ID# 247635	Athens	Attiki	Greece	11527
8	General Hospital of Athens Ippokratio /ID# 247633	Athens	Attiki	Greece	11527
9	University General Hospital Attikon /ID# 248093	Athens	Attiki	Greece	12462
10	University General Hospital of Heraklion PA.G.N.I /ID# 247632	Heraklion	Kriti	Greece	71500
11	Naval Hospital of Athens /ID# 247631	Athens		Greece	11521
12	KAT Atttica General Hospital /ID# 247641	Athens		Greece	14561
13	University General Hospital of Ioannina /ID# 251899	Ioannina		Greece	45500
14	Reg Gen Univ Hosp Larissa /ID# 247642	Larisa		Greece	41110
15	General Hospital of Elefsina Thriassio /ID# 251900	Magoula (Attikis)		Greece	19018
16	Iaso /ID# 247649	Maroussi		Greece	15123
17	Olympion General Clinic SA /ID# 247644	Patras		Greece	26443
18	Bioclinic Thessaloniki /ID# 247648	Thessaloniki		Greece	54622
19	Euromedica Blue Cross Gen Clin /ID# 251898	Thessaloniki		Greece	54636
20	General Hospital of Thessaloniki Hippokrateio /ID# 247643	Thessaloniki		Greece	54642
21	Euromedica General Clinic /ID# 251897	Thessaloniki		Greece	54645
22	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669	Rome	Lazio	Italy	00168
23	Ospedale San Raffaele IRCCS /ID# 251562	Milan	Milano	Italy	20132
24	Istituto Clinico Humanitas /ID# 251275	Rozzano	Milano	Italy	20089
25	Fondazione PTV Policlinico Tor Vergata /ID# 250817	Rome	Roma	Italy	00133
26	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 250819	Ancona		Italy	60126
27	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 251508	Bari		Italy	70124
28	Universita degli Studi del Molise /ID# 251176	Campobasso		Italy	86100
29	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251183	Napoli		Italy	80138
30	Azienda Ospedaliera di Padova /ID# 251265	Padova		Italy	35128
31	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 250789	Palermo		Italy	90127
32	Fondazione IRCCS Policlinico /ID# 250747	Pavia		Italy	27100
33	Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 251146	Siena		Italy	53100
34	Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544	Udine		Italy	33100