A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice
PsABIOnd
Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
2 other identifiers
observational
1,314
19 countries
152
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2021
CompletedFirst Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2027
April 13, 2026
April 1, 2026
5.9 years
August 31, 2021
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
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.
Up to 39 months
The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant
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.
Up to 39 months
Secondary Outcomes (27)
Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively
Baseline up to 39 months
Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)
Baseline up to 39 months
Change from Baseline in Assessment of Dactylitis
Baseline up to 39 months
Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)
Baseline up to 39 months
Change from Baseline in Nail Involvement
Baseline up to 39 months
- +22 more secondary outcomes
Study Arms (2)
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.
Interventions
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.
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.
Eligibility Criteria
The study population consists of participants initially treated for Psoriatic Arthritis (PsA) with guselkumab or interleukin-17 inhibitor (IL-17i) per routine clinical practice in accordance with clinical guidelines.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
OMI
Buenos Aires, C1015ABO, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Hospital J. M. Ramos Mejía
Buenos Aires, C1221ADC, Argentina
Hospital Cordoba
Córdoba, 5000, Argentina
MR Medicina Reumatologica
San Fernando, B1646, Argentina
The Queen Elizabeth Hospital
Adelaide, 5011, Australia
Footscray Hospital, Western Health
Footscray, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
LKH-Univ. Klinikum Graz
Graz, 8036, Austria
Kepler Universitatsklinikum GmbH
Linz, 4021, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Evang. Krankenhaus Gemein. Betriebgesm. Mbh
Vienna, A-1100, Austria
AZ Sint-Jan
Bruges, 8000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
Reumaclinic Genk-Hasselt
Genk, 3600, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Artus Health Centre
Vancouver, British Columbia, V5Z 1J9, Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
St. Claire's Mercy Hospital - Rheumatology Research
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Dr. Juris Lazovskis Incorporated
Coxheath, Nova Scotia, B1L 1B3, Canada
Private Practice - Dr. Pauline Boulos
Dundas, Ontario, L9H 1B7, Canada
Markham Rheumatology Hub
Markham, Ontario, L3R 2C7, Canada
Brandusa Florica Medicine Professional Corporation
Mississauga, Ontario, L5A 3V8, Canada
The Waterside Clinic
Orillia, Ontario, L3V 1T5, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9, Canada
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
G R M O Groupe de recherche en maladies osseuses Inc
Québec, Quebec, G1V 3M7, Canada
Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
Rimouski, Quebec, G5L 5T1, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, G9A 3X2, Canada
Community Rheumatology Care
Saskatoon, Saskatchewan, S7K 0H6, Canada
Rheumatology Associates of Saskatoon
Saskatoon, Saskatchewan, S7K 0H6, Canada
BIOMAB
Bogotá, Colombia
Servimed S A S
Bucaramanga, Colombia
Clinisalud del Sur
Medellín, 50012, Colombia
Clinica Vascular las Americas
Medellín, 50025, Colombia
Funcentra
Montería, 230002, Colombia
Hôpital Avicenne
Bobigny, 93000, France
Centre Hospitalier de Cholet
Cholet, 49300, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
Créteil, 94000, France
CHU Grenoble
Échirolles, 38130, France
CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
Lille, 59037, France
Centre Orthopedique Santy
Lyon, 69008, France
Clinique de l'Infirmerie Protestante de Lyon
Lyon, 69300, France
Hôpital Saint Roch
Nice, 6006, France
CHR Orléans - Nouvel Hôpital Orléans La Source
Orléans, 45032, France
Hôpital Lariboisière - Centre Viggo Petersen
Paris, 75010, France
Hopital Saint-Antoine
Paris, 75012, France
Hôpital Bichat
Paris, 75018, France
Hôpital Pitié-Salpétrière
Paris, 75651, France
CHRU Hôpital de Hautepierre
Strasbourg, 67098, France
Hopital Purpan
Toulouse, 31059, France
Praxis für Rheumatologie
Amberg, 92224, Germany
Rheuma-Praxis Bayreuth
Bayreuth, 95444, Germany
Rheumatologische Schwerpunktpraxis
Berlin, 12161, Germany
Rheumatologische Schwerpunktpraxis 1
Berlin, 13055, Germany
Krankenhaus Porz am Rhein
Cologne, 51149, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, 40225, Germany
Service Rheuma Erfurt
Erfurt, 99096, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Rheumapraxis Dr. Liebhaber
Halle, 6128, Germany
Praxis fur Klinische Studien und Praxis fur Orthopadie
Hamburg, 22415, Germany
Rheumatologie im Struenseehaus
Hamburg, 22767, Germany
Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
Rheumatologische Praxis 1
Leipzig, 04109, Germany
Rheumatologische Praxis
Magdeburg, 39104, Germany
Praxiszentrum St. Bonifatius
München, 81541, Germany
Praxis Thilo Klopsch
Neubrandenburg, 17033, Germany
Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
Püttlingen, 66346, Germany
Rheumazentrum Ratingen
Ratingen, 40878, Germany
Rheumatologisch-immunologische Arztpraxis
Templin, 17268, Germany
Immunologisches Zentrum Vogelsang-Gommern GmbH
Vogelsang-Gommern, 39245, Germany
Evangelismos General Hospital of Athens
Athens, 10676, Greece
Athens Navy Hospital
Athens, 11521, Greece
General Hospital 'Gennimatas'
Athens, 11527, Greece
Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
Athens, 11527, Greece
Laiko General Hospital of Athens
Athens, 11527, Greece
University Hospital of Ioannina
Ioannina, 45560, Greece
'Agios Andreas' General Hospital of Patras
Pátrai, 263 32, Greece
University General Hospital of Rio Patras
Pátrai, 26500, Greece
Ippokrateio Hospital
Thessaloniki, 546 42, Greece
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Ospedale Regionale Cardarelli-Università degli Studi del Mol
Campobasso, 86100, Italy
Universita della Magna grecia
Catanzaro, 88100, Italy
AOU Careggi
Florence, 50141, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
Seconda Univesità degli Studi di Napoli, AOU
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
Potenza, 85100, Italy
Universita Cattolica del Sacro Cuore
Rome, 20123, Italy
Istituto Clinico Humanitas
Rozzano, 20156, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37067, Italy
Kita-harima Medical Center
Hyōgo, 6751392, Japan
Toho University Medical Center, Ohashi Hospital
Meguro-ku, 153-8515, Japan
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
Osaka, 550 0006, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Kyorin University Hospital
Tokyo, 181 8611, Japan
Medical Care & Research SA de CV
Mérida, 97070, Mexico
Consultorio de Reumatologia
México, 07760, Mexico
Hospital Puerta de Hierro
Zapopan, 45116, Mexico
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 1105 AZ, Netherlands
Medisch Spectrum Twente
Enschede, 7500 KA, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
Elkerliek Ziekenhuis
Helmond, 5707 HA, Netherlands
SBEU HPE Kemerovo State Medical Academy
Kemerovo, G4 0SF, Russia
Bakoulev Scientific Center For Cardiovascular Surgery Rams
Moscow, 121552, Russia
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow, 190068, Russia
City Hospital #3
Tomsk, 634045, Russia
Soonchunhyang University Cheonan Hospital
Cheonan-si, 31151, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. Punta de Europa
Algeciras / Cadiz, 11207, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp Univ Vall D Hebron
Barcelona, 8035, Spain
Hosp. Univ. de Basurto
Bilbao, 48013, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Complejo hospitalario de Granada
Granada, 18016, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. de Getafe
Madrid, 28905, Spain
Hosp. Univ. Central de Asturias
Oviedo, 33011, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345, Sweden
Universitetssjukhuset i Lund
Malmo, 20502, Sweden
Universitetssjukhuset Orebro
Örebro, 70185, Sweden
Akademiskt Specialistcentrum centrum för reumatologi
Stockholm, 113 65, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
HFR Fribourg - Hôpital Cantonal
Fribourg, 1708, Switzerland
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 83301, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
NHS Grampian - Aberdeen Royal Infirmary (ARI)
Aberdeen, AB25 2ZB, United Kingdom
Nevill Hall Hospital
Abergavenny, NP7 7EG, United Kingdom
University Hospital Monklands
Airdrie, ML6 0JS, United Kingdom
Royal Free London NHS Foundation Trust Barnet Hospital
Barnet, EN5 3DJ, United Kingdom
Wolfson Centre Royal United Hospitals
Bath, BA1 3NG, United Kingdom
Glasgow Royal Infirmary
Glasgow, 650029, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
Newcastle upon Tyne, NE7 7DN, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Shirley Caldwell
Salford, M6 8HD, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Haywood Hospital
Staffordshire, ST6 7AG, United Kingdom
Stamford and Rutland hospital
Stamford, PE9 1UA, United Kingdom
Wishaw General
Wishaw, ML2 0DP, United Kingdom
Related Publications (1)
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.
PMID: 36585602DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Janssen Pharmaceutica N.V., Belgium
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 20, 2021
Study Start
August 25, 2021
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 2, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share