An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis

Last updated: May 21, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Arthritis And Arthritic Pain

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT06764693
P24-390
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptomonset at least 6 months prior to the Screening visit and fulfillment ofClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm thatthe participant has active disease.

  • Participant must have demonstrated an inadequate response to at least 1Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-InadequateResponse); alternatively, participant must have demonstrated an intolerance to orcontraindication for csDMARDs as determined by the investigator.

Exclusion

Exclusion Criteria:

  • Participants demonstrated an inadequate response to three or more bDMARDs/targetedsynthetic DMARDs (tsDMARDs).

Study Design

Total Participants: 1200
Study Start date:
January 31, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Cer Instituto Médico /ID# 274445

    Quilmes, Buenos Aires 1878
    Argentina

    Active - Recruiting

  • Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417

    San Isidro, Buenos Aires 1643
    Argentina

    Active - Recruiting

  • Instituto Médico Río Cuarto /ID# 274421

    Río Cuarto, Cordoba 5800
    Argentina

    Active - Recruiting

  • ReumaClinic /ID# 272782

    Genk, Limburg 3600
    Belgium

    Active - Recruiting

  • Medical Center Epiona /ID# 276037

    Plovdiv, 4001
    Bulgaria

    Active - Recruiting

  • Chu Montpellier /ID# 274925

    Montpellier CEDEX 5, Herault 34295
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 275397

    Chambray-lès-Tours, Indre-et-Loire 37170
    France

    Active - Recruiting

  • Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208

    Planegg, Bayern 82152
    Germany

    Active - Recruiting

  • Rheumatologisch Immunologisch /ID# 275832

    Templin, Brandenburg 17268
    Germany

    Active - Recruiting

  • Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484

    Frankfurt am Main, Hessen 60329
    Germany

    Active - Recruiting

  • Rheumateam Lahn-Dill-Siegerland /ID# 276019

    Wetzlar, Hessen 35578
    Germany

    Active - Recruiting

  • Praxis. F. Bigdeli-Wilshusen /ID# 275522

    Hanover, Niedersachsen 30173
    Germany

    Active - Recruiting

  • Rheumatologie Kassel /ID# 276311

    Kassel, Niedersachsen 34125
    Germany

    Active - Recruiting

  • Praxis Dr. med. Florian Beyer /ID# 276233

    Kaiserslautern, Rheinland-Pfalz 67657
    Germany

    Active - Recruiting

  • Rheumapraxis Dr. Liebhaber /ID# 276235

    Halle, Sachsen-Anhalt 06128
    Germany

    Active - Recruiting

  • Rheumatologische Facharztpraxis /ID# 276359

    Magdeburg, Sachsen-Anhalt 39104
    Germany

    Active - Recruiting

  • Private Practice - Dr. Thomas Kupka /ID# 276236

    Altenburg, Thueringen 04600
    Germany

    Active - Recruiting

  • MVZ Herzogin Elisabeth Hospital /ID# 275583

    Brunswick, 38114
    Germany

    Active - Recruiting

  • Olympion General Clinic /ID# 271685

    Patras, Achaia 25443
    Greece

    Active - Recruiting

  • General Hospital of Athens Ippokratio /ID# 262528

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • General Hospital of Athens Laiko /ID# 272410

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 272358

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • Asklipieio General Hospital of Voula /ID# 272326

    Voula, Attiki 16673
    Greece

    Active - Recruiting

  • University General Hospital of Alexandroupolis /ID# 272411

    Alexandroupoli, Evros 68100
    Greece

    Active - Recruiting

  • The University Hospital of Larissa /ID# 272315

    Larissa, Larisa 41110
    Greece

    Active - Recruiting

  • KAT Atttica General Hospital /ID# 271741

    Athens, 14561
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion /ID# 271743

    Heraklion, 71500
    Greece

    Active - Recruiting

  • General Hospital of Ioannina G. Hatzikosta /ID# 272327

    Ioannina, 45445
    Greece

    Active - Recruiting

  • Bioclinic Thessaloniki /ID# 272316

    Thessaloniki, 54622
    Greece

    Active - Recruiting

  • Euromedica General Clinic of Thessaloniki /ID# 272412

    Thessaloniki, 54645
    Greece

    Active - Recruiting

  • Euromedica General Clinic of Thessaloniki /ID# 275805

    Thessaloniki, 54645
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki Hippokrateio /ID# 272314

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • St James Hospital /ID# 260024

    Dublin 8, Dublin D08 NHY1
    Ireland

    Active - Recruiting

  • St Vincent's University Hospital /ID# 261237

    Elm Park, Dublin D04 T6F4
    Ireland

    Active - Recruiting

  • University Hospital Kerry /ID# 266733

    Tralee, V92 NX94
    Ireland

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 273313

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas /ID# 264463

    Rozzano, Lombardia 20089
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele /ID# 266212

    Milan, Milano 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 265145

    Rome, Roma 00161
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche /ID# 264636

    Ancona, 60020
    Italy

    Active - Recruiting

  • ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 265640

    Chieti, 67100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana /ID# 264938

    Pisa, 56126
    Italy

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria /ID# 264317

    Málaga, Malaga 29010
    Spain

    Active - Recruiting

  • Hospital Rafael Mendez /ID# 272663

    Lorca, Murcia 30817
    Spain

    Active - Recruiting

  • Hospital Universitario de Valme /ID# 264314

    Seville, Sevilla 41014
    Spain

    Active - Recruiting

  • Hospital Universitario Clinico San Cecilio /ID# 272665

    Granada, 18012
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves /ID# 275741

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Juan Ramón Jiménez /ID# 272667

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 272660

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz /ID# 264316

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa /ID# 264073

    Madrid, 28006
    Spain

    Active - Recruiting

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