Guselkumab: Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with guselkumab, will be observed according to standard clinical practice.
IL-17i: Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with IL-17i, will be observed according to standard clinical practice.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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
Exclusion Criteria:
Main study:
* Start guselkumab or an IL-17i therapy as fifth or further line of biologic treatment
* Have already taken a specific IL-17i or IL-23i treatment and are planning on re-taking that specific treatment again
* Unwilling or unable to participate in long-term data collection
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study (that is, signing of informed consent)
* Currently enrolled in any interventional study or any Janssen-sponsored observational clinical study (contemporary participation into observational studies or registries not sponsored by Janssen is acceptable)
Substudy:
* Have an insufficient command of language to interact effectively with the smartphone application, in the opinion of the investigator at each site
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the well-being) or that could prevent, limit, or confound assessment
* Unwilling or unable to comply with substudy assessments
Primary outcome measure(s)
The Start and Stop Date of Guselkumab, as Applicable, For Each Participant — Up to 39 months The start and stop date, (first and last administration date, respectively) of guselkumab, as applicable, for each participant will be collected to document treatment persistence.
The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant — Up to 39 months The start and stop date (first and last administration date respectively) of IL-17i, as applicable, for each participant will be collected to document treatment persistence.
Trial sites (155)
Facility
City
Region
Status
OMI
Buenos Aires
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires
Argentina
Hospital J. M. Ramos Mejía
Buenos Aires
Argentina
Hospital Cordoba
Córdoba
Argentina
MR Medicina Reumatologica
San Fernando
Argentina
The Queen Elizabeth Hospital
Adelaide
Australia
Footscray Hospital, Western Health
Footscray
Australia
Royal North Shore Hospital
St Leonards
Australia
LKH-Univ. Klinikum Graz
Graz
Austria
Kepler Universitatsklinikum GmbH
Linz
Austria
Medizinische Universitaet Wien
Vienna
Austria
Evang. Krankenhaus Gemein. Betriebgesm. Mbh
Vienna
Austria
AZ Sint-Jan
Bruges
Belgium
Hopital Erasme
Brussels
Belgium
Reumaclinic Genk-Hasselt
Genk
Belgium
UZ Leuven
Leuven
Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège
Belgium
Artus Health Centre
Vancouver
British Columbia
Manitoba Clinic
Winnipeg
Manitoba
St. Claire's Mercy Hospital - Rheumatology Research
St. John's
Newfoundland and Labrador
Dr. Juris Lazovskis Incorporated
Coxheath
Nova Scotia
Private Practice - Dr. Pauline Boulos
Dundas
Ontario
Markham Rheumatology Hub
Markham
Ontario
Brandusa Florica Medicine Professional Corporation
Mississauga
Ontario
The Waterside Clinic
Orillia
Ontario
The Ottawa Hospital Research Institute
Ottawa
Ontario
Dr Sabeen Anwar Medicine Professional Corporation
Windsor
Ontario
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal
Quebec
G R M O Groupe de recherche en maladies osseuses Inc
Québec
Quebec
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
Rimouski
Quebec
Centre de Recherche Musculo Squelettique
Trois-Rivières
Quebec
Community Rheumatology Care
Saskatoon
Saskatchewan
Rheumatology Associates of Saskatoon
Saskatoon
Saskatchewan
BIOMAB
Bogotá
Colombia
Servimed S A S
Bucaramanga
Colombia
Clinisalud del Sur
Medellín
Colombia
Clinica Vascular las Americas
Medellín
Colombia
Funcentra
Montería
Colombia
Hôpital Avicenne
Bobigny
France
Centre Hospitalier de Cholet
Cholet
France
+ 115 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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