An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis
Recruiting · NCT06764693 · Observational (researchers observe without assigning treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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).
Where it is running
60 locations listed.
- Azienda Ospedaliero Universitaria delle Marche /ID# 264636 - Ancona, Italy
- KAT Atttica General Hospital /ID# 271741 - Athens, Greece
- Rheumapraxis Steglitz /ID# 279413 - Berlin, Germany
- Private Practice - Dr. Silke Zinke /ID# 279350 - Berlin, Germany
- MVZ Herzogin Elisabeth Hospital /ID# 275583 - Braunschweig, Germany
- ASST degli Spedali Civili di Brescia /ID# 264699 - Brescia, Italy
- CH de Cahors /ID# 275092 - Cahors, France
- Universita degli Studi del Molise /ID# 265162 - Campobasso, Italy
- AOU Policlinico G. Rodolico - San Marco /ID# 264459 - Catania, Italy
- ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 265640 - Chieti, Italy
- Cork University Hospital /ID# 268263 - Cork, Ireland
- Beaumont Hospital /ID# 271961 - Dublin, Ireland
- Tallaght University Hospital /ID# 277000 - Dublin, Ireland
- Hospital Universitario Virgen de las Nieves /ID# 275741 - Granada, Spain
- Hospital Universitario Clinico San Cecilio /ID# 272665 - Granada, Spain
- Praxis Fiene /ID# 279363 - Greifswald, Germany
- The Lady Davis Carmel Medical Center /ID# 273312 - Haifa, Israel
- Hospital Juan Ramón Jiménez /ID# 272667 - Huelva, Spain
- General Hospital of Ioannina G. Hatzikosta /ID# 272327 - Ioannina, Greece
- Hadassah Medical Center-Hebrew University /ID# 273314 - Jerusalem, Israel
- CHU de Liege /ID# 272784 - Liège, Belgium
- 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
- Hospital General Universitario Reina Sofía /ID# 272664 - Murcia, Spain
- Galilee Medical Center /ID# 275431 - Nahariya, Israel
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 274352 - New Taipei City, Taiwan
- Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 275377 - Orléans, France
- AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 275182 - Paris, France
- Groupe Hospitalier Paris Saint-Joseph /ID# 274981 - Paris, France
- Azienda Ospedaliero Universitaria Pisana /ID# 264938 - Pisa, Italy
- Military Hospital - Pleven /ID# 276054 - Pleven, Bulgaria
- Medical Center Epiona /ID# 276037 - Plovdiv, Bulgaria
- University Multiprofile Hospital For Active Treatment Pulmed /ID# 276157 - Plovdiv, Bulgaria
- Azienda Ospedaliera Universitaria Senese /ID# 265207 - Siena, Italy
- Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158 - Sofia, Bulgaria
- Medical Center Academy /ID# 276041 - Sofia, Bulgaria
- Taichung Veterans General Hospital /ID# 274896 - Taichung, Taiwan
- National Taiwan University Hospital /ID# 280714 - Taipei, Taiwan
- Bioclinic Thessaloniki /ID# 272316 - Thessaloniki, Greece
- General Hospital of Thessaloniki Hippokrateio /ID# 272314 - Thessaloniki, Greece
- Euromedica General Clinic of Thessaloniki /ID# 272412 - Thessaloniki, Greece
- Euromedica General Clinic of Thessaloniki /ID# 275805 - Thessaloniki, Greece
- ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 264698 - Udine, Italy
- Centre Hospitalier de Valenciennes /ID# 276354 - Valenciennes, France
- AIPSMPR -d-r Gerganov /ID# 275953 - Varna, Bulgaria
- Cellitinnen-Krankenhaus St. Josef /ID# 275710 - Wuppertal, Germany
- Olympion General Clinic /ID# 271685 - Pátrai, Achaia, Greece
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923 - Nice, Alpes-Maritimes, France
- Athens Naval Hospital /ID# 272313 - Athens, Attica, Greece
- General Hospital of Athens Ippokratio /ID# 262528 - Athens, Attica, Greece
- General Hospital of Athens Laiko /ID# 272325 - Athens, Attica, Greece
- General Hospital of Athens Laiko /ID# 272410 - Athens, Attica, Greece
- University General Hospital Attikon /ID# 272358 - Athens, Attica, Greece
- Asklipieio General Hospital of Voula /ID# 272326 - Voula, Attica, Greece
- Infirmerie Protestante De Lyon /ID# 274922 - Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
- Centre Hospitalier Universitaire Gabriel-Montpied /ID# 275399 - Clermont-Ferrand, Auvergne-Rhône-Alpes, France
- Chu Grenoble - Hôpital Sud /ID# 275200 - Échirolles, Auvergne-Rhône-Alpes, France
- Dr. Med. Thomas Marycz /ID# 280489 - Amberg, Bavaria, Germany
- Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208 - Planegg, Bavaria, Germany
Showing 60 of 132 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →