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

NCT ID: NCT05049798

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1314 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2027-08-01

Brief 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).

Detailed Description

Psoriatic arthritis (PsA) is a seronegative inflammatory spondylarthritis associated with psoriasis (PsO), which can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes (dactylitis), inflammation of the muscle- or tendon insertions at adjacent bone (enthesitis), as well as raised red patches or various other expressions of psoriasis on the skin. Guselkumab (TREMFYA) is a fully human immunoglobulin G1 lambda (IgG1) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL) 23 with high specificity and affinity, blocking IL-23 binding. Binding of guselkumab to the IL-23p19 subunit blocks the subsequent binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine production. Participants with confirmed diagnosis of PsA who are starting guselkumab or any marketed interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of PsA biologic therapy per standard clinical practice will be enrolled in the main study. The aim of main study is to document the use of guselkumab and approved IL-17i therapies in routine clinical practice in patients with PsA who are starting guselkumab or an IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy. The overall duration of the main study, including recruitment and follow-up, is expected to be about 6 years. Participants who are starting guselkumab or an IL-17i treatment per routine clinical practice in the main study, and who meet the selection criteria for both the main study and substudy, will be consecutively offered entry into the substudy (a select number) at the time of enrollment into the main study. The substudy aims to collect additional data, continuously or with increased frequency, on the impact of guselkumab or IL-17i on patient mood, physical activity, sleep disturbance, disease symptoms, and health-related quality-of-life (HRQoL). Total duration of the substudy will be approximately 26-30 weeks consisting of a pre-treatment period of up to 14 days before the first dose of guselkumab or IL-17i in the main study and a 24-week (plus [+] up to 4 weeks follow-up) observation period.

Conditions

Arthritis, Psoriatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Guselkumab

Intervention Type: DRUG

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.

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.

IL-17i

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

TREMFYA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

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, Canada

Manitoba Clinic

Winnipeg, Manitoba, Canada

Riverside Professional Centre

Sydney, Nova Scotia, Canada

Private Practice - Dr. Pauline Boulos

Dundas, Ontario, Canada

Markham Rheumatology Hub

Markham, Ontario, Canada

Brandusa Florica Medicine Professional Corporation

Mississauga, Ontario, Canada

The Waterside Clinic

Orillia, Ontario, Canada

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Dr Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, Canada

CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

G R M O Groupe de recherche en maladies osseuses Inc

Québec, Quebec, Canada

Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski

Rimouski, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Centre de Recherche Musculo Squelettique

Trois-Rivières, Quebec, Canada

Community Rheumatology Care

Saskatoon, Saskatchewan, Canada

Rheumatology Associates of Saskatoon

Saskatoon, Saskatchewan, Canada

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

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

Créteil, , France

CHU Grenoble

Échirolles, , France

CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur

Lille, , France

Centre Orthopedique Santy

Lyon, , France

Clinique de l'Infirmerie Protestante de Lyon

Lyon, , France

Hôpital Saint Roch

Nice, , France

CHR Orléans - Nouvel Hôpital Orléans La Source

Orléans, , France

Hôpital Lariboisière - Centre Viggo Petersen

Paris, , France

Hopital Saint-Antoine

Paris, , France

Hôpital Bichat

Paris, , France

Hôpital Pitié-Salpétrière

Paris, , France

CHRU Hôpital de Hautepierre

Strasbourg, , France

Hopital Purpan

Toulouse, , France

Praxis für Rheumatologie

Amberg, , Germany

Rheuma-Praxis Bayreuth

Bayreuth, , Germany

Rheumatologische Schwerpunktpraxis

Berlin, , Germany

Rheumatologische Schwerpunktpraxis

Berlin, , Germany

Krankenhaus Porz am Rhein

Cologne, , Germany

Universitatsklinikum Dusseldorf

Düsseldorf, , Germany

Service Rheuma Erfurt

Erfurt, , Germany

Universitatsklinikum Frankfurt

Frankfurt, , Germany

Rheumapraxis Dr. Liebhaber

Halle, , Germany

Praxis fur Klinische Studien und Praxis fur Orthopadie

Hamburg, , Germany

Rheumatologie im Struenseehaus

Hamburg, , Germany

Rheumazentrum Ruhrgebiet

Herne, , Germany

Rheumatologische Praxis

Leipzig, , Germany

Rheumatologische Praxis

Magdeburg, , Germany

Praxiszentrum St. Bonifatius

München, , Germany

Praxis Thilo Klopsch

Neubrandenburg, , Germany

Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie

Püttlingen, , Germany

Rheumazentrum Ratingen

Ratingen, , Germany

Rheumatologisch-immunologische Arztpraxis

Templin, , Germany

Immunologisches Zentrum Vogelsang-Gommern GmbH

Vogelsang-Gommern, , Germany

Evangelismos General Hospital of Athens

Athens, , Greece

Athens Navy Hospital

Athens, , Greece

General Hospital 'Gennimatas'

Athens, , Greece

Hippokration General Hospital of Athens, B' Internal Medicine Clinic,

Athens, , Greece

Laiko General Hospital of Athens

Athens, , Greece

University Hospital of Ioannina

Ioannina, , Greece

'Agios Andreas' General Hospital of Patras

Pátrai, , Greece

University General Hospital of Rio Patras

Pátrai, , Greece

Ippokrateio Hospital

Thessaloniki, , Greece

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Ospedale Regionale Cardarelli-Università degli Studi del Mol

Campobasso, , Italy

Universita della Magna grecia

Catanzaro, , Italy

AOU Careggi

Florence, , Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Seconda Univesità degli Studi di Napoli, AOU

Napoli, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

Potenza, , Italy

Universita Cattolica del Sacro Cuore

Rome, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Azienda Ospedaliero Universitaria S.Maria Della Misericordia

Udine, , Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Kita-harima Medical Center

Hyōgo, , Japan

Toho University Medical Center, Ohashi Hospital

Meguro-ku, , Japan

Osaka Metropolitan University Hospital

Osaka, , Japan

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Kyorin University Hospital

Tokyo, , Japan

Medical Care & Research SA de CV

Mérida, , Mexico

Consultorio de Reumatologia

México, , Mexico

Hospital Puerta de Hierro

Zapopan, , Mexico

Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Elkerliek Ziekenhuis

Helmond, , Netherlands

SBEU HPE Kemerovo State Medical Academy

Kemerovo, , Russia

Bakoulev Scientific Center For Cardiovascular Surgery Rams

Moscow, , Russia

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, , Russia

City Hospital #3

Tomsk, , Russia

Soonchunhyang University Cheonan Hospital

Cheonan-si, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Punta de Europa

Algeciras / Cadiz, , Spain

Hosp Clinic de Barcelona

Barcelona, , Spain

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. Univ. de Basurto

Bilbao, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Complejo hospitalario de Granada

Granada, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. de Getafe

Madrid, , Spain

Hosp. Univ. Central de Asturias

Oviedo, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Universitetssjukhuset i Lund

Lund, , Sweden

Universitetssjukhuset Orebro

Örebro, , Sweden

Akademiskt Specialistcentrum centrum för reumatologi

Stockholm, , Sweden

Akademiska Sjukhuset

Uppsala, , Sweden

HFR Fribourg - Hôpital Cantonal

Fribourg, , Switzerland

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Chang Gung Medical Foundation

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

NHS Grampian - Aberdeen Royal Infirmary (ARI)

Aberdeen, , United Kingdom

Nevill Hall Hospital

Abergavenny, , United Kingdom

University Hospital Monklands

Airdrie, , United Kingdom

Royal Free London NHS Foundation Trust Barnet Hospital

Barnet, , United Kingdom

Wolfson Centre Royal United Hospitals

Bath, , United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Hull Royal Infirmary

Hull, , United Kingdom

Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital

Leeds, , United Kingdom

Central Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

Newcastle upon Tyne, , United Kingdom

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Shirley Caldwell

Salford, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Haywood Hospital

Staffordshire, , United Kingdom

Stamford and Rutland hospital

Stamford, , United Kingdom

Wishaw General

Wishaw, , United Kingdom

Countries

Brazil; Argentina; Australia; Austria; Belgium; Canada; Colombia; France; Germany; Greece; Italy; Japan; Mexico; Netherlands; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

Siebert S, Behrens F, Lubrano E, Martin N, Sharaf M, Contre C, Theander E, Queiro R, Zimmermann M, Gossec L. PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis. Rheumatol Ther. 2023 Apr;10(2):489-505. doi: 10.1007/s40744-022-00518-w. Epub 2022 Dec 30.

Reference Type: DERIVED

PMID: 36585602 (View on PubMed)

Other Identifiers

CNTO1959PSA4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108938

Identifier Type: -

Identifier Source: org_study_id