- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764693
An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis (PERIS)
Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shari Chapman
- Phone Number: 844-663-3742
- Email: shari.chapman@abbvie.com
Study Locations
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Buenos Aires
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Quilmes, Buenos Aires, Argentina, 1878
- Recruiting
- Cer Instituto Médico /ID# 274445
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San Isidro, Buenos Aires, Argentina, 1642
- Recruiting
- Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417
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Córdoba Province
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Río Cuarto, Córdoba Province, Argentina, 5800
- Recruiting
- Instituto Médico Río Cuarto /ID# 274421
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Lower Austria
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Stockerau, Lower Austria, Austria, 2000
- Recruiting
- Landesklinikum Stockerau /ID# 275618
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Styria
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Graz, Styria, Austria, 8010
- Recruiting
- Medizinische Universitaet Graz /ID# 273765
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Graz, Styria, Austria, 8020
- Recruiting
- Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764
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Vienna
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Vienna, Vienna, Austria, 1100
- Recruiting
- Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617
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Liège, Belgium, 4000
- Recruiting
- CHU de Liege /ID# 272784
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Brussels Capital
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Anderlecht, Brussels Capital, Belgium, 1070
- Recruiting
- Universite Libre de Bruxelles - Hopital Erasme /ID# 272763
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Hainaut
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Charleroi, Hainaut, Belgium, 6000
- Recruiting
- Rhumaconsult Sprl /ID# 272797
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Limburg
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Genk, Limburg, Belgium, 3600
- Recruiting
- ReumaClinic /ID# 272782
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Genk, Limburg, Belgium, 3600
- Recruiting
- Reumacentrum Genk - Medisch Centrum Genk /ID# 272796
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Oost-Vlaanderen
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Aalst, Oost-Vlaanderen, Belgium, 9300
- Recruiting
- OLV Ziekenhuis Aalst /ID# 274456
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- UZ Leuven /ID# 272781
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Pleven, Bulgaria, 5803
- Recruiting
- Military Hospital - Pleven /ID# 276054
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Plovdiv, Bulgaria, 4001
- Recruiting
- Medical Center Epiona /ID# 276037
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Plovdiv, Bulgaria, 4002
- Recruiting
- University Multiprofile Hospital For Active Treatment Pulmed /ID# 276157
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Sofia, Bulgaria, 1408
- Recruiting
- Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158
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Sofia, Bulgaria, 1612
- Recruiting
- Medical Center Academy /ID# 276041
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Varna, Bulgaria, 9002
- Recruiting
- AIPSMPR -d-r Gerganov /ID# 275953
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Sofia
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Sofiya, Sofia, Bulgaria, 1463
- Recruiting
- Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 275952
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Ostrava-mesto
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Ostrava, Ostrava-mesto, Czechia, 710 00
- Recruiting
- MAPO revma /ID# 272409
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Praha 17
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Pilsen, Praha 17, Czechia, 301 00
- Recruiting
- Fakultni Nemocnice Plzen /ID# 276061
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Cahors, France, 46005
- Recruiting
- CH de Cahors /ID# 275092
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Orléans, France, 45067
- Recruiting
- Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 275377
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Paris, France, 75010
- Recruiting
- AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 275182
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Paris, France, 75014
- Recruiting
- Groupe Hospitalier Paris Saint-Joseph /ID# 274981
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Valenciennes, France, 59300
- Recruiting
- Centre Hospitalier de Valenciennes /ID# 276354
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06001
- Recruiting
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923
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Auvergne-Rhône-Alpes
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Caluire-et-Cuire, Auvergne-Rhône-Alpes, France, 69300
- Recruiting
- Infirmerie Protestante De Lyon /ID# 274922
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Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
- Recruiting
- Centre Hospitalier Universitaire Gabriel-Montpied /ID# 275399
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Échirolles, Auvergne-Rhône-Alpes, France, 38130
- Recruiting
- Chu Grenoble - Hôpital Sud /ID# 275200
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Doubs
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Besançon, Doubs, France, 25000
- Recruiting
- Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 277881
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Hauts-de-France
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Arras, Hauts-de-France, France, 62022
- Recruiting
- Centre Hospitalier D'Arras /ID# 275192
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Lille, Hauts-de-France, France, 59037
- Recruiting
- CHU de Lille - Hôpital Salengro /ID# 274980
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Herault
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Montpellier, Herault, France, 34295
- Recruiting
- Chu Montpellier /ID# 274925
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35203
- Recruiting
- Chru De Rennes - Hôpital Sud /ID# 277115
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Indre-et-Loire
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Chambray-lès-Tours, Indre-et-Loire, France, 37170
- Recruiting
- Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 275397
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Limousin
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Limoges, Limousin, France, 87039
- Recruiting
- Clinique François Chénieux /ID# 276516
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Nouvelle-Aquitaine
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Limoges, Nouvelle-Aquitaine, France, 87000
- Recruiting
- CHU Limoges - Dupuytren 2 /ID# 274918
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Occitanie
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Montauban, Occitanie, France, 82000
- Recruiting
- Pôle Santé du Pont de Chaume /ID# 275608
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Pas-de-Calais
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Boulogne-sur-Mer, Pas-de-Calais, France, 62321
- Recruiting
- Centre Hospitalier Boulogne-Sur-Mer /ID# 277269
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, France, 44000
- Recruiting
- Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275396
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Provence-Alpes-Côte d'Azur Region
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Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, France, 13080
- Recruiting
- Hôpital Privé De Provence /ID# 275797
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Cannes, Provence-Alpes-Côte d'Azur Region, France, 06414
- Recruiting
- Centre Hospitalier De Cannes - Hôpital De Cannes /ID# 275193
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Seine-Maritime
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Rouen, Seine-Maritime, France, 76031
- Recruiting
- Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 275366
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Somme
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Péronne, Somme, France, 80200
- Recruiting
- Cabinet libéral du Dr PAUPIERE /ID# 275401
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Val-de-Marne
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Créteil, Val-de-Marne, France, 94000
- Recruiting
- Henri Mondor Hospital /ID# 275360
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Île-de-France Region
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Corbeil-Essonnes, Île-de-France Region, France, 91106
- Recruiting
- Centre Hospitalier Sud Francilien /ID# 275038
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Paris, Île-de-France Region, France, 75013
- Recruiting
- Hopital Pitie Salpetriere /ID# 275368
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Berlin, Germany, 12161
- Recruiting
- Rheumapraxis Steglitz /ID# 279413
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Berlin, Germany, 13055
- Recruiting
- Private Practice - Dr. Silke Zinke /ID# 279350
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Braunschweig, Germany, 38114
- Recruiting
- MVZ Herzogin Elisabeth Hospital /ID# 275583
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Greifswald, Germany, 17493
- Recruiting
- Praxis Fiene /ID# 279363
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Wuppertal, Germany, 42105
- Recruiting
- Cellitinnen-Krankenhaus St. Josef /ID# 275710
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Bavaria
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Amberg, Bavaria, Germany, 92224
- Recruiting
- Dr. Med. Thomas Marycz /ID# 280489
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Planegg, Bavaria, Germany, 82152
- Recruiting
- Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208
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Brandenburg
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Hohen Neuendorf, Brandenburg, Germany, 16540
- Recruiting
- Private Practice - Dr. Dirk Wernicke /ID# 279748
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Templin, Brandenburg, Germany, 17268
- Recruiting
- Rheumatologisch Immunologisch /ID# 275832
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Hesse
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Frankfurt am Main, Hesse, Germany, 60329
- Recruiting
- Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484
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Wetzlar, Hesse, Germany, 35578
- Recruiting
- Rheumateam Lahn-Dill-Siegerland /ID# 276019
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30173
- Recruiting
- Praxis. F. Bigdeli-Wilshusen /ID# 275522
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Kassel, Lower Saxony, Germany, 34125
- Recruiting
- Rheumatologie Kassel /ID# 276311
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North Rhine-Westphalia
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Ratingen, North Rhine-Westphalia, Germany, 40882
- Recruiting
- Rheumazentrum Ratingen /ID# 278190
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Rhineland-Palatinate
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Kaiserslautern, Rhineland-Palatinate, Germany, 67657
- Recruiting
- Praxis Dr. med. Florian Beyer /ID# 276233
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Trier, Rhineland-Palatinate, Germany, 54292
- Recruiting
- Krankenhaus der Barmherzigen Brüder Trier /ID# 278759
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Saarland
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Püttlingen, Saarland, Germany, 66346
- Recruiting
- Knappschaftsklinikum Saar /ID# 279850
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Püttlingen, Saarland, Germany, 66346
- Recruiting
- Rheumapraxis Dr. Prothmann /ID# 275712
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Germany, 06128
- Recruiting
- Rheumapraxis Dr. Liebhaber /ID# 276235
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Magdeburg, Saxony-Anhalt, Germany, 39104
- Recruiting
- Rheumatologische Facharztpraxis /ID# 276359
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- Recruiting
- Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 275711
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Rendsburg, Schleswig-Holstein, Germany, 24768
- Recruiting
- Private Practice - Dr. Jochen Walter /ID# 280067
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Thuringia
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Altenburg, Thuringia, Germany, 04600
- Completed
- Private Practice - Dr. Thomas Kupka /ID# 276236
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Athens, Greece, 14561
- Recruiting
- KAT Atttica General Hospital /ID# 271741
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Ioannina, Greece, 45445
- Recruiting
- General Hospital of Ioannina G. Hatzikosta /ID# 272327
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Thessaloniki, Greece, 54622
- Recruiting
- Bioclinic Thessaloniki /ID# 272316
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Thessaloniki, Greece, 54642
- Recruiting
- General Hospital of Thessaloniki Hippokrateio /ID# 272314
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Thessaloniki, Greece, 54645
- Recruiting
- Euromedica General Clinic of Thessaloniki /ID# 272412
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Thessaloniki, Greece, 54645
- Recruiting
- Euromedica General Clinic of Thessaloniki /ID# 275805
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Achaia
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Pátrai, Achaia, Greece, 25443
- Recruiting
- Olympion General Clinic /ID# 271685
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Attica
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Athens, Attica, Greece, 11527
- Recruiting
- General Hospital of Athens Ippokratio /ID# 262528
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Athens, Attica, Greece, 11527
- Recruiting
- General Hospital of Athens Laiko /ID# 272325
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Athens, Attica, Greece, 11527
- Recruiting
- General Hospital of Athens Laiko /ID# 272410
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Athens, Attica, Greece, 12462
- Recruiting
- University General Hospital Attikon /ID# 272358
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Athens, Attica, Greece, 11521
- Recruiting
- Athens Naval Hospital /ID# 272313
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Voula, Attica, Greece, 16673
- Recruiting
- Asklipieio General Hospital of Voula /ID# 272326
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Crete
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Heraklion, Crete, Greece, 71500
- Recruiting
- University General Hospital of Heraklion /ID# 271743
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Evros
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Alexandroupoli, Evros, Greece, 68100
- Recruiting
- University General Hospital of Alexandroupolis /ID# 272411
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Larisa
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Larissa, Larisa, Greece, 41110
- Recruiting
- The University Hospital of Larissa /ID# 272315
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Cork, Ireland, T12 E8YV
- Recruiting
- Cork University Hospital /ID# 268263
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Dublin, Ireland, D09 XR63
- Recruiting
- Beaumont Hospital /ID# 271961
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Dublin, Ireland, D24 NR0A
- Recruiting
- Tallaght University Hospital /ID# 277000
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Contact:
- Site Coordinator
- Phone Number: 01 414 3350
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Dublin
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Dublin, Dublin, Ireland, D08 NHY1
- Recruiting
- St James Hospital /ID# 260024
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Elm Park, Dublin, Ireland, D04 T6F4
- Recruiting
- St Vincents University Hospital /ID# 261237
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Kerry
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Tralee, Kerry, Ireland, V92 NX94
- Recruiting
- University Hospital Kerry /ID# 266733
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Haifa, Israel, 34362
- Recruiting
- The Lady Davis Carmel Medical Center /ID# 273312
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Jerusalem, Israel, 91120
- Recruiting
- Hadassah Medical Center-Hebrew University /ID# 273314
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Nahariya, Israel, 2210001
- Recruiting
- Galilee Medical Center /ID# 275431
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Central District
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Kfar Saba, Central District, Israel, 4428164
- Recruiting
- Meir Medical Center /ID# 273315
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 5265601
- Recruiting
- The Chaim Sheba Medical Center /ID# 273313
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Tel Aviv, Tel Aviv, Israel, 6423906
- Recruiting
- Tel Aviv Sourasky Medical Center /ID# 273311
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Ancona, Italy, 60020
- Recruiting
- Azienda Ospedaliero Universitaria delle Marche /ID# 264636
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Brescia, Italy, 25123
- Recruiting
- ASST degli Spedali Civili di Brescia /ID# 264699
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Campobasso, Italy, 86100
- Recruiting
- Universita degli Studi del Molise /ID# 265162
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Catania, Italy, 95123
- Recruiting
- AOU Policlinico G. Rodolico - San Marco /ID# 264459
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Contact:
- Site Coordinator
- Phone Number: +39-957-435-045
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Chieti, Italy, 67100
- Recruiting
- ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 265640
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Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero Universitaria Pisana /ID# 264938
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Siena, Italy, 53100
- Recruiting
- Azienda Ospedaliera Universitaria Senese /ID# 265207
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Udine, Italy, 33100
- Recruiting
- ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 264698
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Lombardy
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Rozzano, Lombardy, Italy, 20089
- Recruiting
- IRCCS Istituto Clinico Humanitas /ID# 264463
-
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Milano
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Milan, Milano, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele /ID# 266212
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Milan, Milano, Italy, 20122
- Recruiting
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 265161
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Napoli
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Naples, Napoli, Italy, 80138
- Recruiting
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 266888
-
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Roma
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Rome, Roma, Italy, 00161
- Recruiting
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 265145
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Poland, 61-324
- Recruiting
- Indywidualna Specjalistyczna Praktyka Lekarska dr hab.n.med.Katarzyna Pawlak-Buś /ID# 276483
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Contact:
- Site Coordinator
- Phone Number: +48 601 446 031
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 52-317
- Recruiting
- SOMED Renata Sokolik /ID# 276480
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-
-
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Eastern Province
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Dammam, Eastern Province, Saudi Arabia, 34212
- Recruiting
- Imam Abdulrahman Bin Faisal University /ID# 277716
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Riyadh Region
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Riyadh, Riyadh Region, Saudi Arabia, 12372
- Recruiting
- King Saud University /ID# 279463
-
-
-
-
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Granada, Spain, 18014
- Recruiting
- Hospital Universitario Virgen de las Nieves /ID# 275741
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Granada, Spain, 18016
- Recruiting
- Hospital Universitario Clinico San Cecilio /ID# 272665
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Huelva, Spain, 21005
- Recruiting
- Hospital Juan Ramón Jiménez /ID# 272667
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz /ID# 264316
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Madrid, Spain, 28006
- Recruiting
- Hospital Universitario de La Princesa /ID# 264073
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre /ID# 272660
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Murcia, Spain, 30003
- Recruiting
- Hospital General Universitario Reina Sofía /ID# 272664
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Malaga
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Málaga, Malaga, Spain, 29010
- Recruiting
- Hospital Universitario Virgen de la Victoria /ID# 264317
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Murcia
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Lorca, Murcia, Spain, 30817
- Recruiting
- Hospital Rafael Mendez /ID# 272663
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Pontevedra
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Vigo, Pontevedra, Spain, 36204
- Recruiting
- Hospital Xeral Cies (CHUVI) /ID# 272659
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Sevilla
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Seville, Sevilla, Spain, 41014
- Recruiting
- Hospital Universitario de Valme /ID# 264314
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-
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New Taipei City, Taiwan, 235
- Recruiting
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 274352
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Taichung, Taiwan, 407
- Recruiting
- Taichung Veterans General Hospital /ID# 274896
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital /ID# 280714
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.
|
|
Biologic Disease-Modifying Antirheumatic Drugs (bDMARD)
Participants will receive bDMARDs as prescribed by their physician according to local label.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants that show persistence in treatment until 24 months
Time Frame: 24 Months
|
Persistence over 24 months, defined as a participant who starts PsA treatment and is still on the same therapy until 24 months.
|
24 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P24-390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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