Clinical trial NCT06764693: An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis
Official title: Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Keywords: Risankizumab, Skyrizi
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that currently are treated with Risankizumab or other advanced treatment options for the management of active psoriatic arthritis in clinical practice.

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 an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice.

Risankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents.

The therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months.

There is expected to be no additional burden for participants in this study.


Eligibility criteria: Inclusion Criteria:

* Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease.
* Participant must have demonstrated an inadequate response to at least 1 Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-Inadequate Response); alternatively, participant must have demonstrated an intolerance to or contraindication for csDMARDs as determined by the investigator.

Exclusion Criteria:

- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).

Primary outcomes:
measure: Number of participants that show persistence in treatment until 24 months
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Quilmes
country: Argentina
facility: Cer Instituto Médico /ID# 274445
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417
state: Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto /ID# 274421
state: Cordoba
city: Genk
country: Belgium
facility: ReumaClinic /ID# 272782
state: Limburg
city: Plovdiv
country: Bulgaria
facility: Medical Center Epiona /ID# 276037
city: Montpellier CEDEX 5
country: France
facility: Chu Montpellier /ID# 274925
state: Herault
city: Chambray-lès-Tours
country: France
facility: Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 275397
state: Indre-et-Loire
city: Planegg
country: Germany
facility: Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208
state: Bayern
city: Templin
country: Germany
facility: Rheumatologisch Immunologisch /ID# 275832
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484
state: Hessen
city: Wetzlar
country: Germany
facility: Rheumateam Lahn-Dill-Siegerland /ID# 276019
state: Hessen
city: Hanover
country: Germany
facility: Praxis. F. Bigdeli-Wilshusen /ID# 275522
state: Niedersachsen
city: Kassel
country: Germany
facility: Rheumatologie Kassel /ID# 276311
state: Niedersachsen
city: Kaiserslautern
country: Germany
facility: Praxis Dr. med. Florian Beyer /ID# 276233
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Rheumapraxis Dr. Liebhaber /ID# 276235
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Rheumatologische Facharztpraxis /ID# 276359
state: Sachsen-Anhalt
city: Altenburg
country: Germany
facility: Private Practice - Dr. Thomas Kupka /ID# 276236
state: Thueringen
city: Brunswick
country: Germany
facility: MVZ Herzogin Elisabeth Hospital /ID# 275583
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 271685
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 262528
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 272410
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 272358
state: Attiki
city: Voula
country: Greece
facility: Asklipieio General Hospital of Voula /ID# 272326
state: Attiki
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupolis /ID# 272411
state: Evros
city: Larissa
country: Greece
facility: The University Hospital of Larissa /ID# 272315
state: Larisa
city: Athens
country: Greece
facility: KAT Atttica General Hospital /ID# 271741
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion /ID# 271743
city: Ioannina
country: Greece
facility: General Hospital of Ioannina G. Hatzikosta /ID# 272327
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki /ID# 272316
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 272314
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki /ID# 272412
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki /ID# 275805
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 260024
state: Dublin
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital /ID# 261237
state: Dublin
city: Tralee
country: Ireland
facility: University Hospital Kerry /ID# 266733
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 273313
state: Tel-Aviv
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 264463
state: Lombardia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 266212
state: Milano
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 265145
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 264636
city: Chieti
country: Italy
facility: ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 265640
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 264938
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 264317
state: Malaga
city: Lorca
country: Spain
facility: Hospital Rafael Mendez /ID# 272663
state: Murcia
city: Seville
country: Spain
facility: Hospital Universitario de Valme /ID# 264314
state: Sevilla
city: Granada
country: Spain
facility: Hospital Universitario Clinico San Cecilio /ID# 272665
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 275741
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez /ID# 272667
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa /ID# 264073
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 272660
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 264316
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: