Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

Status: Active_not_recruiting
Location: See all (155) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

⁃ Main study:

• Have a confirmed diagnosis of PsA as determined by a rheumatologist with reference to Classification criteria for Psoriatic Arthritis (CASPAR)

• Start guselkumab or any approved interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy for the indication of PsA as part of standard clinical practice (according to local label, local regulations, and/or reimbursement requirements) at the time of enrollment into the observational study or within a maximum of 2 months after the initial baseline visit or after repeated baseline data collection

• Sign a participation agreement/Informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

• Able to read, understand, and intend to comply with completion of all Electronic patient-reported outcome (ePRO) instruments

• The treatment decision must be taken by the participating rheumatologist prior to, and independently of the participant's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations

⁃ Substudy:

• Must sign the substudy ICF allowing data collection in accordance with local requirements

• Is scheduled to receive guselkumab or IL-17i, per routine clinical practice, in the main study

• Currently using or is willing to use wearables and/or commercial applications to track their disease within the course of their normal daily activities

Locations
Other Locations
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital J. M. Ramos Mejía
Buenos Aires
OMI
Buenos Aires
Hospital Cordoba
Córdoba
MR Medicina Reumatologica
San Fernando
Australia
The Queen Elizabeth Hospital
Adelaide
Footscray Hospital, Western Health
Footscray
Royal North Shore Hospital
St Leonards
Austria
LKH-Univ. Klinikum Graz
Graz
Kepler Universitatsklinikum GmbH
Linz
Evang. Krankenhaus Gemein. Betriebgesm. Mbh
Vienna
Medizinische Universitaet Wien
Vienna
Belgium
AZ Sint-Jan
Bruges
Hopital Erasme
Brussels
Reumaclinic Genk-Hasselt
Genk
UZ Leuven
Leuven
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège
Canada
Private Practice - Dr. Pauline Boulos
Dundas
Markham Rheumatology Hub
Markham
Brandusa Florica Medicine Professional Corporation
Mississauga
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal
The Waterside Clinic
Orillia
The Ottawa Hospital Research Institute
Ottawa
G R M O Groupe de recherche en maladies osseuses Inc
Québec
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
Rimouski
Community Rheumatology Care
Saskatoon
Rheumatology Associates of Saskatoon
Saskatoon
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke
Riverside Professional Centre
Sydney
Centre de Recherche Musculo Squelettique
Trois-rivières
Artus Health Centre
Vancouver
Dr Sabeen Anwar Medicine Professional Corporation
Windsor
Manitoba Clinic
Winnipeg
Colombia
BIOMAB
Bogotá
Servimed S A S
Bucaramanga
Clinica Vascular las Americas
Medellín
Clinisalud del Sur
Medellín
Funcentra
Montería
France
Hôpital Avicenne
Bobigny
Centre Hospitalier de Cholet
Cholet
Hôpital Gabriel Montpied
Clermont-ferrand
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
Créteil
CHU Grenoble
Échirolles
CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
Lille
Centre Orthopedique Santy
Lyon
Clinique de l'Infirmerie Protestante de Lyon
Lyon
Hôpital Saint Roch
Nice
CHR Orléans - Nouvel Hôpital Orléans La Source
Orléans
Hôpital Bichat
Paris
Hôpital Lariboisière - Centre Viggo Petersen
Paris
Hôpital Pitié-Salpétrière
Paris
Hopital Saint-Antoine
Paris
CHRU Hôpital de Hautepierre
Strasbourg
Hopital Purpan
Toulouse
Germany
Praxis für Rheumatologie
Amberg
Rheuma-Praxis Bayreuth
Bayreuth
Rheumatologische Schwerpunktpraxis
Berlin
Rheumatologische Schwerpunktpraxis
Berlin
Krankenhaus Porz am Rhein
Cologne
Universitatsklinikum Dusseldorf
Düsseldorf
Service Rheuma Erfurt
Erfurt
Universitatsklinikum Frankfurt
Frankfurt
Rheumapraxis Dr. Liebhaber
Halle
Praxis fur Klinische Studien und Praxis fur Orthopadie
Hamburg
Rheumatologie im Struenseehaus
Hamburg
Rheumazentrum Ruhrgebiet
Herne
Rheumatologische Praxis
Leipzig
Rheumatologische Praxis
Magdeburg
Praxiszentrum St. Bonifatius
München
Praxis Thilo Klopsch
Neubrandenburg
Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
Püttlingen
Rheumazentrum Ratingen
Ratingen
Rheumatologisch-immunologische Arztpraxis
Templin
Immunologisches Zentrum Vogelsang-Gommern GmbH
Vogelsang-gommern
Greece
Athens Navy Hospital
Athens
Evangelismos General Hospital of Athens
Athens
General Hospital 'Gennimatas'
Athens
Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
Athens
Laiko General Hospital of Athens
Athens
University Hospital of Ioannina
Ioannina
'Agios Andreas' General Hospital of Patras
Pátrai
University General Hospital of Rio Patras
Pátrai
Ippokrateio Hospital
Thessaloniki
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari
Ospedale Regionale Cardarelli-Università degli Studi del Mol
Campobasso
Universita della Magna grecia
Catanzaro
AOU Careggi
Florence
Azienda Ospedaliera Universitaria Federico II
Napoli
Seconda Univesità degli Studi di Napoli, AOU
Napoli
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo
Azienda Ospedaliero Universitaria Pisana
Pisa
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
Potenza
Universita Cattolica del Sacro Cuore
Rome
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Japan
Kita-harima Medical Center
Hyōgo
Toho University Medical Center, Ohashi Hospital
Meguro-ku
Osaka Metropolitan University Hospital
Osaka
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
Osaka
Hokkaido University Hospital
Sapporo
Kyorin University Hospital
Tokyo
Mexico
Medical Care & Research SA de CV
Mérida
Consultorio de Reumatologia
México
Hospital Puerta de Hierro
Zapopan
Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam
Medisch Spectrum Twente
Enschede
Universitair Medisch Centrum Groningen
Groningen
Elkerliek Ziekenhuis
Helmond
Republic of Korea
Soonchunhyang University Cheonan Hospital
Cheonan-si
Seoul National University Bundang Hospital
Seongnam
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Russian Federation
SBEU HPE Kemerovo State Medical Academy
Kemerovo
Bakoulev Scientific Center For Cardiovascular Surgery Rams
Moscow
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow
City Hospital #3
Tomsk
Spain
Hosp Univ A Coruna
A Coruña
Hosp. Punta de Europa
Algeciras / Cadiz
Hosp Clinic de Barcelona
Barcelona
Hosp Univ Vall D Hebron
Barcelona
Hosp. Univ. de Basurto
Bilbao
Hosp Reina Sofia
Córdoba
Complejo hospitalario de Granada
Granada
Hosp. Univ. 12 de Octubre
Madrid
Hosp. Univ. de Getafe
Madrid
Hosp. Univ. Central de Asturias
Oviedo
Hosp. Clinico Univ. de Santiago
Santiago De Compostela
Hosp. Virgen Del Rocio
Seville
Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg
Universitetssjukhuset i Lund
Lund
Universitetssjukhuset Orebro
Örebro
Akademiskt Specialistcentrum centrum för reumatologi
Stockholm
Akademiska Sjukhuset
Uppsala
Switzerland
HFR Fribourg - Hôpital Cantonal
Fribourg
Taiwan
Chang Gung Medical Foundation
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
United Kingdom
NHS Grampian - Aberdeen Royal Infirmary (ARI)
Aberdeen
Nevill Hall Hospital
Abergavenny
University Hospital Monklands
Airdrie
Royal Free London NHS Foundation Trust Barnet Hospital
Barnet
Wolfson Centre Royal United Hospitals
Bath
Glasgow Royal Infirmary
Glasgow
Hull Royal Infirmary
Hull
Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital
Leeds
Central Manchester University Hospitals NHS Foundation Trust
Manchester
The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
Newcastle Upon Tyne
Queen Alexandra Hospital
Portsmouth
Shirley Caldwell
Salford
Southampton General Hospital
Southampton
Haywood Hospital
Staffordshire
Stamford and Rutland hospital
Stamford
Wishaw General
Wishaw
Time Frame
Start Date: 2021-08-25
Completion Date: 2027-08-01
Participants
Target number of participants: 1314
Treatments
Cohort 1: Guselkumab
Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of Psoriatic Arthritis (PsA) who are starting guselkumab as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice in main study. Participants who meet the selection criteria for both the main study and substudy, will be consecutively offered to be enrolled into the substudy at the time of enrollment into the main study.
Cohort 2: Interleukin-17 inhibitor (IL-17i)
Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of PsA who are starting IL-17i as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice in main study. Participants who meet the selection criteria for both the main study and substudy, will be consecutively offered to be enrolled into the substudy at the time of enrollment into the main study.
Related Therapeutic Areas
Sponsors
Leads: Janssen Pharmaceutica N.V., Belgium

This content was sourced from clinicaltrials.gov