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Clinical Trials in the UK / NCT05049798
Active, not recruiting Observational

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

NCT05049798 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Pharmaceutica N.V., Belgium
Phase
Observational
Started
2021-08-25
Last updated
2026-08-28

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

GuselkumabIL-17i

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)

Trial sites (155)

FacilityCityRegionStatus
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.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Pharmaceutica N.V., Belgium trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT05049798 on ClinicalTrials.gov ↗ ← All trials in the UK