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

NCT ID: NCT06764693

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis

Keywords

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Risankizumab, Skyrizi

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biologic Disease-Modifying Antirheumatic Drugs (bDMARD)

Participants will receive bDMARDs as prescribed by their physician according to local label.

No interventions assigned to this group

Risankizumab

Participants will receive risankizumab as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Cer Instituto Médico /ID# 274445

Quilmes, Buenos Aires, Argentina

Site Status RECRUITING

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

San Isidro, Buenos Aires, Argentina

Site Status RECRUITING

Instituto Médico Río Cuarto /ID# 274421

Río Cuarto, Córdoba Province, Argentina

Site Status RECRUITING

Landesklinikum Stockerau /ID# 275618

Stockerau, Lower Austria, Austria

Site Status RECRUITING

Medizinische Universitaet Graz /ID# 273765

Graz, Styria, Austria

Site Status RECRUITING

Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764

Graz, Styria, Austria

Site Status RECRUITING

Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617

Vienna, Vienna, Austria

Site Status RECRUITING

Universite Libre de Bruxelles - Hopital Erasme /ID# 272763

Anderlecht, Brussels Capital, Belgium

Site Status RECRUITING

Rhumaconsult Sprl /ID# 272797

Charleroi, Hainaut, Belgium

Site Status RECRUITING

Reumacentrum Genk - Medisch Centrum Genk /ID# 272796

Genk, Limburg, Belgium

Site Status RECRUITING

ReumaClinic /ID# 272782

Genk, Limburg, Belgium

Site Status RECRUITING

OLV Ziekenhuis Aalst /ID# 274456

Aalst, Oost-Vlaanderen, Belgium

Site Status RECRUITING

UZ Leuven /ID# 272781

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

CHU de Liege /ID# 272784

Liège, , Belgium

Site Status RECRUITING

Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 275952

Sofiya, Sofia, Bulgaria

Site Status RECRUITING

Military Hospital - Pleven /ID# 276054

Pleven, , Bulgaria

Site Status RECRUITING

Medical Center Epiona /ID# 276037

Plovdiv, , Bulgaria

Site Status RECRUITING

Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158

Sofia, , Bulgaria

Site Status RECRUITING

Medical Center Academy /ID# 276041

Sofia, , Bulgaria

Site Status RECRUITING

AIPSMPR -d-r Gerganov /ID# 275953

Varna, , Bulgaria

Site Status RECRUITING

MAPO revma /ID# 272409

Ostrava, Ostrava-mesto, Czechia

Site Status RECRUITING

Fakultni Nemocnice Plzen /ID# 276061

Pilsen, Praha 17, Czechia

Site Status RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923

Nice, Alpes-Maritimes, France

Site Status RECRUITING

Infirmerie Protestante De Lyon /ID# 274922

Caluire-et-Cuire, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Centre Hospitalier Universitaire Gabriel-Montpied /ID# 275399

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Chu Grenoble - Hôpital Sud /ID# 275200

Échirolles, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 277881

Besançon, Doubs, France

Site Status RECRUITING

Centre Hospitalier D'Arras /ID# 275192

Arras, Hauts-de-France, France

Site Status RECRUITING

CHU de Lille - Hôpital Salengro /ID# 274980

Lille, Hauts-de-France, France

Site Status RECRUITING

Chu Montpellier /ID# 274925

Montpellier, Herault, France

Site Status RECRUITING

Chru De Rennes - Hôpital Sud /ID# 277115

Rennes, Ille-et-Vilaine, France

Site Status RECRUITING

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

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

Site Status RECRUITING

Clinique François Chénieux /ID# 276516

Limoges, Limousin, France

Site Status RECRUITING

CHU Limoges - Dupuytren 2 /ID# 274918

Limoges, Nouvelle-Aquitaine, France

Site Status RECRUITING

Pôle Santé du Pont de Chaume /ID# 275608

Montauban, Occitanie, France

Site Status RECRUITING

Centre Hospitalier Boulogne-Sur-Mer /ID# 277269

Boulogne-sur-Mer, Pas-de-Calais, France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275396

Nantes, Pays de la Loire Region, France

Site Status RECRUITING

Hôpital Privé De Provence /ID# 275797

Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, France

Site Status RECRUITING

Centre Hospitalier De Cannes - Hôpital De Cannes /ID# 275193

Cannes, Provence-Alpes-Côte d'Azur Region, France

Site Status RECRUITING

Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 275366

Rouen, Seine-Maritime, France

Site Status RECRUITING

Cabinet libéral du Dr PAUPIERE /ID# 275401

Péronne, Somme, France

Site Status RECRUITING

Henri Mondor Hospital /ID# 275360

Créteil, Val-de-Marne, France

Site Status RECRUITING

CH de Cahors /ID# 275092

Cahors, , France

Site Status RECRUITING

Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 275377

Orléans, , France

Site Status RECRUITING

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 275182

Paris, , France

Site Status RECRUITING

Groupe Hospitalier Paris Saint-Joseph /ID# 274981

Paris, , France

Site Status RECRUITING

Centre Hospitalier de Valenciennes /ID# 276354

Valenciennes, , France

Site Status RECRUITING

Centre Hospitalier Sud Francilien /ID# 275038

Corbeil-Essonnes, Île-de-France Region, France

Site Status RECRUITING

Hopital Pitie Salpetriere /ID# 275368

Paris, Île-de-France Region, France

Site Status RECRUITING

Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208

Planegg, Bavaria, Germany

Site Status RECRUITING

Private Practice - Dr. Dirk Wernicke /ID# 279748

Hohen Neuendorf, Brandenburg, Germany

Site Status RECRUITING

Rheumatologisch Immunologisch /ID# 275832

Templin, Brandenburg, Germany

Site Status RECRUITING

Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Rheumateam Lahn-Dill-Siegerland /ID# 276019

Wetzlar, Hesse, Germany

Site Status RECRUITING

Praxis. F. Bigdeli-Wilshusen /ID# 275522

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Rheumatologie Kassel /ID# 276311

Kassel, Lower Saxony, Germany

Site Status RECRUITING

Rheumazentrum Ratingen /ID# 278190

Ratingen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Praxis Dr. med. Florian Beyer /ID# 276233

Kaiserslautern, Rhineland-Palatinate, Germany

Site Status RECRUITING

Krankenhaus der Barmherzigen Brüder Trier /ID# 278759

Trier, Rhineland-Palatinate, Germany

Site Status RECRUITING

Knappschaftsklinikum Saar /ID# 279850

Püttlingen, Saarland, Germany

Site Status RECRUITING

Rheumapraxis Dr. Prothmann /ID# 275712

Püttlingen, Saarland, Germany

Site Status RECRUITING

Rheumapraxis Dr. Liebhaber /ID# 276235

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Rheumatologische Facharztpraxis /ID# 276359

Magdeburg, Saxony-Anhalt, Germany

Site Status RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 275711

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Private Practice - Dr. Jochen Walter /ID# 280067

Rendsburg, Schleswig-Holstein, Germany

Site Status RECRUITING

Private Practice - Dr. Thomas Kupka /ID# 276236

Altenburg, Thuringia, Germany

Site Status COMPLETED

Rheumapraxis Steglitz /ID# 279413

Berlin, , Germany

Site Status RECRUITING

Private Practice - Dr. Silke Zinke /ID# 279350

Berlin, , Germany

Site Status RECRUITING

MVZ Herzogin Elisabeth Hospital /ID# 275583

Braunschweig, , Germany

Site Status RECRUITING

Praxis Fiene /ID# 279363

Greifswald, , Germany

Site Status RECRUITING

Cellitinnen-Krankenhaus St. Josef /ID# 275710

Wuppertal, , Germany

Site Status RECRUITING

Olympion General Clinic /ID# 271685

Pátrai, Achaia, Greece

Site Status RECRUITING

Athens Naval Hospital /ID# 272313

Athens, Attica, Greece

Site Status RECRUITING

General Hospital of Athens Ippokratio /ID# 262528

Athens, Attica, Greece

Site Status RECRUITING

General Hospital of Athens Laiko /ID# 272325

Athens, Attica, Greece

Site Status RECRUITING

General Hospital of Athens Laiko /ID# 272410

Athens, Attica, Greece

Site Status RECRUITING

University General Hospital Attikon /ID# 272358

Athens, Attica, Greece

Site Status RECRUITING

Asklipieio General Hospital of Voula /ID# 272326

Voula, Attica, Greece

Site Status RECRUITING

University General Hospital of Heraklion /ID# 271743

Heraklion, Crete, Greece

Site Status RECRUITING

University General Hospital of Alexandroupolis /ID# 272411

Alexandroupoli, Evros, Greece

Site Status RECRUITING

The University Hospital of Larissa /ID# 272315

Larissa, Larisa, Greece

Site Status RECRUITING

KAT Atttica General Hospital /ID# 271741

Athens, , Greece

Site Status RECRUITING

General Hospital of Ioannina G. Hatzikosta /ID# 272327

Ioannina, , Greece

Site Status RECRUITING

Bioclinic Thessaloniki /ID# 272316

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki Hippokrateio /ID# 272314

Thessaloniki, , Greece

Site Status RECRUITING

Euromedica General Clinic of Thessaloniki /ID# 272412

Thessaloniki, , Greece

Site Status RECRUITING

Euromedica General Clinic of Thessaloniki /ID# 275805

Thessaloniki, , Greece

Site Status RECRUITING

St James Hospital /ID# 260024

Dublin, Dublin, Ireland

Site Status RECRUITING

St Vincents University Hospital /ID# 261237

Elm Park, Dublin, Ireland

Site Status RECRUITING

University Hospital Kerry /ID# 266733

Tralee, Kerry, Ireland

Site Status RECRUITING

Cork University Hospital /ID# 268263

Cork, , Ireland

Site Status RECRUITING

Beaumont Hospital /ID# 271961

Dublin, , Ireland

Site Status RECRUITING

Tallaght University Hospital /ID# 277000

Dublin, , Ireland

Site Status RECRUITING

Meir Medical Center /ID# 273315

Kfar Saba, Central District, Israel

Site Status RECRUITING

The Chaim Sheba Medical Center /ID# 273313

Ramat Gan, Tel Aviv, Israel

Site Status RECRUITING

Tel Aviv Sourasky Medical Center /ID# 273311

Tel Aviv, Tel Aviv, Israel

Site Status RECRUITING

The Lady Davis Carmel Medical Center /ID# 273312

Haifa, , Israel

Site Status RECRUITING

Hadassah Medical Center-Hebrew University /ID# 273314

Jerusalem, , Israel

Site Status RECRUITING

Galilee Medical Center /ID# 275431

Nahariya, , Israel

Site Status RECRUITING

IRCCS Istituto Clinico Humanitas /ID# 264463

Rozzano, Lombardy, Italy

Site Status RECRUITING

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 265161

Milan, Milano, Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele /ID# 266212

Milan, Milano, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 266888

Naples, Napoli, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 265145

Rome, Roma, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria delle Marche /ID# 264636

Ancona, , Italy

Site Status RECRUITING

ASST degli Spedali Civili di Brescia /ID# 264699

Brescia, , Italy

Site Status RECRUITING

Universita degli Studi del Molise /ID# 265162

Campobasso, , Italy

Site Status RECRUITING

AOU Policlinico G. Rodolico - San Marco /ID# 264459

Catania, , Italy

Site Status RECRUITING

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

Chieti, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana /ID# 264938

Pisa, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Senese /ID# 265207

Siena, , Italy

Site Status RECRUITING

ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 264698

Udine, , Italy

Site Status RECRUITING

Indywidualna Specjalistyczna Praktyka Lekarska dr hab.n.med.Katarzyna Pawlak-Buś /ID# 276483

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

SOMED Renata Sokolik /ID# 276480

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Imam Abdulrahman Bin Faisal University /ID# 277716

Dammam, Eastern Province, Saudi Arabia

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria /ID# 264317

Málaga, Malaga, Spain

Site Status RECRUITING

Hospital Rafael Mendez /ID# 272663

Lorca, Murcia, Spain

Site Status RECRUITING

Hospital Xeral Cies (CHUVI) /ID# 272659

Vigo, Pontevedra, Spain

Site Status RECRUITING

Hospital Universitario de Valme /ID# 264314

Seville, Sevilla, Spain

Site Status RECRUITING

Hospital Universitario Virgen de las Nieves /ID# 275741

Granada, , Spain

Site Status RECRUITING

Hospital Universitario Clinico San Cecilio /ID# 272665

Granada, , Spain

Site Status RECRUITING

Hospital Juan Ramón Jiménez /ID# 272667

Huelva, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa /ID# 264073

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre /ID# 272660

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz /ID# 264316

Madrid, , Spain

Site Status RECRUITING

Hospital General Universitario Reina Sofía /ID# 272664

Murcia, , Spain

Site Status RECRUITING

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 274352

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Argentina Austria Belgium Bulgaria Czechia France Germany Greece Ireland Israel Italy Poland Saudi Arabia Spain Taiwan

Central Contacts

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Shari Chapman

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Facility Contacts

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Site Coordinator

Role: primary

Site Coordinator

Role: primary

Site Coordinator

Role: primary

Related Links

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Other Identifiers

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P24-390

Identifier Type: -

Identifier Source: org_study_id