Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06764693
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that show persistence in treatment until 24 months', 'timeFrame': '24 Months', 'description': 'Persistence over 24 months, defined as a participant who starts PsA treatment and is still on the same therapy until 24 months.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risankizumab, Skyrizi'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=P24-390', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nRisankizumab 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.\n\nThe 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.\n\nThere is expected to be no additional burden for participants in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants that currently are treated with Risankizumab or other advanced treatment options for the management of active psoriatic arthritis in clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n\nExclusion Criteria:\n\n\\- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).'}, 'identificationModule': {'nctId': 'NCT06764693', 'acronym': 'PERIS', 'briefTitle': 'An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)', 'orgStudyIdInfo': {'id': 'P24-390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biologic Disease-Modifying Antirheumatic Drugs (bDMARD)', 'description': 'Participants will receive bDMARDs as prescribed by their physician according to local label.'}, {'label': 'Risankizumab', 'description': 'Participants will receive risankizumab as prescribed by their physician according to local label.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1878', 'city': 'Quilmes', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Cer Instituto Médico /ID# 274445', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'zip': '1642', 'city': 'San Isidro', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417', 'geoPoint': {'lat': -34.46971, 'lon': -58.52111}}, {'zip': '5800', 'city': 'Río Cuarto', 'state': 'Córdoba Province', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto Médico Río Cuarto /ID# 274421', 'geoPoint': {'lat': -33.13044, 'lon': -64.35272}}, {'zip': '2000', 'city': 'Stockerau', 'state': 'Lower Austria', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Landesklinikum Stockerau /ID# 275618', 'geoPoint': {'lat': 48.38333, 'lon': 16.21667}}, {'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz /ID# 273765', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8020', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Anderlecht', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universite Libre de Bruxelles - Hopital Erasme /ID# 272763', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '6000', 'city': 'Charleroi', 'state': 'Hainaut', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Rhumaconsult Sprl /ID# 272797', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Reumacentrum Genk - Medisch Centrum Genk /ID# 272796', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'ReumaClinic /ID# 272782', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9300', 'city': 'Aalst', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'OLV Ziekenhuis Aalst /ID# 274456', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'UZ Leuven /ID# 272781', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU de Liege /ID# 272784', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1463', 'city': 'Sofiya', 'state': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 275952'}, {'zip': '5803', 'city': 'Pleven', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Military Hospital - Pleven /ID# 276054', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4001', 'city': 'Plovdiv', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Epiona /ID# 276037', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1408', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1612', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Medical Center Academy /ID# 276041', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9002', 'city': 'Varna', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'AIPSMPR -d-r Gerganov /ID# 275953', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '710 00', 'city': 'Ostrava', 'state': 'Ostrava-mesto', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'MAPO revma /ID# 272409', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '301 00', 'city': 'Pilsen', 'state': 'Praha 17', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice Plzen /ID# 276061', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '06001', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69300', 'city': 'Caluire-et-Cuire', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Infirmerie Protestante De Lyon /ID# 274922', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Gabriel-Montpied /ID# 275399', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38130', 'city': 'Échirolles', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Grenoble - Hôpital Sud /ID# 275200', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 277881', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '62022', 'city': 'Arras', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'facility': "Centre Hospitalier D'Arras /ID# 275192", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Lille - Hôpital Salengro /ID# 274980', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Herault', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Montpellier /ID# 274925', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '35203', 'city': 'Rennes', 'state': 'Ille-et-Vilaine', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chru De Rennes - Hôpital Sud /ID# 277115', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'state': 'Indre-et-Loire', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 275397', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '87039', 'city': 'Limoges', 'state': 'Limousin', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Clinique François Chénieux /ID# 276516', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87000', 'city': 'Limoges', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Limoges - Dupuytren 2 /ID# 274918', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '82000', 'city': 'Montauban', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Pôle Santé du Pont de Chaume /ID# 275608', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '62321', 'city': 'Boulogne-sur-Mer', 'state': 'Pas-de-Calais', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Boulogne-Sur-Mer /ID# 277269', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275396', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '13080', 'city': 'Aix-en-Provence', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Privé De Provence /ID# 275797', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '06414', 'city': 'Cannes', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier De Cannes - Hôpital De Cannes /ID# 275193', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '76031', 'city': 'Rouen', 'state': 'Seine-Maritime', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 275366', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '80200', 'city': 'Péronne', 'state': 'Somme', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Cabinet libéral du Dr PAUPIERE /ID# 275401', 'geoPoint': {'lat': 49.93218, 'lon': 2.9363}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Val-de-Marne', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Henri Mondor Hospital /ID# 275360', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '46005', 'city': 'Cahors', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CH de Cahors /ID# 275092', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '45067', 'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'facility': "Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 275377", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 275182', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph /ID# 274981', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '59300', 'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier de Valenciennes /ID# 276354', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '91106', 'city': 'Corbeil-Essonnes', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien /ID# 275038', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Pitie Salpetriere /ID# 275368', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '82152', 'city': 'Planegg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208', 'geoPoint': {'lat': 48.10672, 'lon': 11.42483}}, {'zip': '16540', 'city': 'Hohen Neuendorf', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Private Practice - Dr. Dirk Wernicke /ID# 279748', 'geoPoint': {'lat': 52.67631, 'lon': 13.27775}}, {'zip': '17268', 'city': 'Templin', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumatologisch Immunologisch /ID# 275832', 'geoPoint': {'lat': 53.11865, 'lon': 13.5022}}, {'zip': '60329', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '35578', 'city': 'Wetzlar', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Rheumateam Lahn-Dill-Siegerland /ID# 276019', 'geoPoint': {'lat': 50.56109, 'lon': 8.50495}}, {'zip': '30173', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Praxis. 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