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

Recruiting

• Conditions: Psoriatic Arthritis

• Registration Number: NCT06764693
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-08
• Study Start: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants that show persistence in treatment until 24 months	24 Months	Persistence over 24 months, defined as a participant who starts PsA treatment and is still on the same therapy until 24 months.

Trial Locations

Locations (51)

Euromedica General Clinic of Thessaloniki /ID# 275805; 🇬🇷 Thessaloniki, Greece

Cer Instituto Médico /ID# 274445; 🇦🇷 Quilmes, Buenos Aires, Argentina

Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417; 🇦🇷 San Isidro, Buenos Aires, Argentina

Instituto Médico Río Cuarto /ID# 274421; 🇦🇷 Río Cuarto, Cordoba, Argentina

ReumaClinic /ID# 272782; 🇧🇪 Genk, Limburg, Belgium

Medical Center Epiona /ID# 276037; 🇧🇬 Plovdiv, Bulgaria

Chu Montpellier /ID# 274925; 🇫🇷 Montpellier CEDEX 5, Herault, France

Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 275397; 🇫🇷 Chambray-lès-Tours, Indre-et-Loire, France

Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208; 🇩🇪 Planegg, Bayern, Germany

Rheumatologisch Immunologisch /ID# 275832; 🇩🇪 Templin, Brandenburg, Germany

Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484; 🇩🇪 Frankfurt am Main, Hessen, Germany

Rheumateam Lahn-Dill-Siegerland /ID# 276019; 🇩🇪 Wetzlar, Hessen, Germany

Praxis. F. Bigdeli-Wilshusen /ID# 275522; 🇩🇪 Hanover, Niedersachsen, Germany

Rheumatologie Kassel /ID# 276311; 🇩🇪 Kassel, Niedersachsen, Germany

Praxis Dr. med. Florian Beyer /ID# 276233; 🇩🇪 Kaiserslautern, Rheinland-Pfalz, Germany

Rheumapraxis Dr. Liebhaber /ID# 276235; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Rheumatologische Facharztpraxis /ID# 276359; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Private Practice - Dr. Thomas Kupka /ID# 276236; 🇩🇪 Altenburg, Thueringen, Germany

MVZ Herzogin Elisabeth Hospital /ID# 275583; 🇩🇪 Brunswick, Germany

Olympion General Clinic /ID# 271685; 🇬🇷 Patras, Achaia, Greece

General Hospital of Athens Ippokratio /ID# 262528; 🇬🇷 Athens, Attiki, Greece

General Hospital of Athens Laiko /ID# 272410; 🇬🇷 Athens, Attiki, Greece

University General Hospital Attikon /ID# 272358; 🇬🇷 Athens, Attiki, Greece

Asklipieio General Hospital of Voula /ID# 272326; 🇬🇷 Voula, Attiki, Greece

University General Hospital of Alexandroupolis /ID# 272411; 🇬🇷 Alexandroupoli, Evros, Greece

The University Hospital of Larissa /ID# 272315; 🇬🇷 Larissa, Larisa, Greece

KAT Atttica General Hospital /ID# 271741; 🇬🇷 Athens, Greece

University General Hospital of Heraklion /ID# 271743; 🇬🇷 Heraklion, Greece

General Hospital of Ioannina G. Hatzikosta /ID# 272327; 🇬🇷 Ioannina, Greece

Bioclinic Thessaloniki /ID# 272316; 🇬🇷 Thessaloniki, Greece

General Hospital of Thessaloniki Hippokrateio /ID# 272314; 🇬🇷 Thessaloniki, Greece

Euromedica General Clinic of Thessaloniki /ID# 272412; 🇬🇷 Thessaloniki, Greece

St James Hospital /ID# 260024; 🇮🇪 Dublin 8, Dublin, Ireland

St Vincent's University Hospital /ID# 261237; 🇮🇪 Elm Park, Dublin, Ireland

University Hospital Kerry /ID# 266733; 🇮🇪 Tralee, Ireland

The Chaim Sheba Medical Center /ID# 273313; 🇮🇱 Ramat Gan, Tel-Aviv, Israel

IRCCS Istituto Clinico Humanitas /ID# 264463; 🇮🇹 Rozzano, Lombardia, Italy

IRCCS Ospedale San Raffaele /ID# 266212; 🇮🇹 Milan, Milano, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 265145; 🇮🇹 Rome, Roma, Italy

Azienda Ospedaliero Universitaria delle Marche /ID# 264636; 🇮🇹 Ancona, Italy

ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 265640; 🇮🇹 Chieti, Italy

Azienda Ospedaliero Universitaria Pisana /ID# 264938; 🇮🇹 Pisa, Italy

Hospital Universitario Virgen de la Victoria /ID# 264317; 🇪🇸 Málaga, Malaga, Spain

Hospital Rafael Mendez /ID# 272663; 🇪🇸 Lorca, Murcia, Spain

Hospital Universitario de Valme /ID# 264314; 🇪🇸 Seville, Sevilla, Spain

Hospital Universitario Clinico San Cecilio /ID# 272665; 🇪🇸 Granada, Spain

Hospital Universitario Virgen de las Nieves /ID# 275741; 🇪🇸 Granada, Spain

Hospital Juan Ramón Jiménez /ID# 272667; 🇪🇸 Huelva, Spain

Hospital Universitario de La Princesa /ID# 264073; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 272660; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz /ID# 264316; 🇪🇸 Madrid, Spain