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

Last Updated   April 24, 2024 - 21:10

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    - phase
  • Sites
    154 sites
  • Status
    Recruiting

SUMMARY

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

ELIGIBILITY

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 regulationsSubstudy:* 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

DETAILS

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.

LOCATIONS

Locations in:
United Kingdom, Taiwan, Switzerland, Sweden, Spain, South Korea, Russia, Netherlands, Mexico, Japan, Italy, Greece, Germany, France, Colombia, Canada, Belgium, Austria, Australia, Argentina
Country (20) City or Province (154) Status
United Kingdom Aberdeen NHS Grampian - Aberdeen Royal Infirmary (ARI)
RECRUITING
United Kingdom Abergavenny, MON Nevill Hall Hospital
RECRUITING
United Kingdom Airdrie University Hospital Monklands
RECRUITING
United Kingdom Bath Wolfson Centre Royal United Hospitals
RECRUITING
United Kingdom Glasgow Glasgow Royal Infirmary
RECRUITING
United Kingdom Hull Hull Royal Infirmary
RECRUITING
United Kingdom Leeds, WYK Chapel Allerton Hospital
RECRUITING
United Kingdom London Kings College Hospital
RECRUITING
United Kingdom Manchester Central Manchester University Hospitals NHS Foundation Trust
RECRUITING
United Kingdom Newcastle Upon Tyne The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
RECRUITING
United Kingdom Portsmouth Queen Alexandra Hospital
RECRUITING
United Kingdom Salford Shirley Caldwell
RECRUITING
United Kingdom Southampton Southampton General Hospital
RECRUITING
United Kingdom Staffordshire Haywood Hospital
RECRUITING
United Kingdom Stamford, LIN Stamford and Rutland hospital
RECRUITING
United Kingdom Wishaw Wishaw General
RECRUITING
Taiwan Kaohsiung Chang Gung Medical Foundation
RECRUITING
Taiwan Kaohsiung Kaohsiung Veterans General Hospital
RECRUITING
Taiwan Taichung Taichung Veterans General Hospital
RECRUITING
Switzerland Fribourg, FR HFR Fribourg - Hôpital Cantonal
RECRUITING
Sweden Göteborg Sahlgrenska Universitetssjukhuset
RECRUITING
Sweden Lund Universitetssjukhuset i Lund
RECRUITING
Sweden Orebro Universitetssjukhuset Orebro
RECRUITING
Sweden Stockholm Akademiskt Specialistcentrum centrum för reumatologi
RECRUITING
Sweden Uppsala Akademiska Sjukhuset
RECRUITING
Spain A Coruna Hosp. Univ. A Coruna
RECRUITING
Spain Algeciras / Cadiz Hosp. Punta de Europa
RECRUITING
Spain Barcelona, BA Hosp. Clinic de Barcelona
RECRUITING
Spain Barcelona, BA Hosp. Univ. Vall D Hebron
RECRUITING
Spain Bilbao Hosp. Univ. de Basurto
RECRUITING
Spain Cordoba Hosp. Reina Sofia
RECRUITING
Spain Granada, GD Complejo hospitalario de Granada
RECRUITING
Spain Madrid, MD Hosp. Univ. 12 de Octubre
RECRUITING
Spain Madrid, MD Hosp. Univ. de Getafe
RECRUITING
Spain Oviedo, AS Hosp. Univ. Central de Asturias
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
South Korea Cheonan-si, 44 Soonchunhyang University Cheonan Hospital
RECRUITING
South Korea Seongnam, 41 Seoul National University Bundang Hospital
COMPLETED
South Korea Seoul Seoul Metropolitan Government Seoul National University Boramae Medical Center
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
Russia Kemerovo SBEU HPE Kemerovo State Medical Academy
TERMINATED
Russia Moscow Bakoulev Scientific Center For Cardiovascular Surgery Rams
TERMINATED
Russia Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova
COMPLETED
Russia Tomsk City Hospital #3
TERMINATED
Netherlands Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam
RECRUITING
Netherlands Enschede, OV Medisch Spectrum Twente
RECRUITING
Netherlands Groningen, GR Universitair Medisch Centrum Groningen
RECRUITING
Netherlands Helmond Elkerliek Ziekenhuis
RECRUITING
Mexico Merida Medical Care & Research SA de CV
RECRUITING
Mexico Mexico Consultorio de Reumatologia
RECRUITING
Mexico Zapopan, JAL Hospital Puerta de Hierro
RECRUITING
Japan Hyogo, 28 Kita-harima Medical Center
RECRUITING
Japan Meguro-ku, 13 Toho University Medical Center, Ohashi Hospital
RECRUITING
Japan Osaka, 27 Osaka Metropolitan University Hospital
RECRUITING
Japan Osaka, 27 Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
RECRUITING
Japan Sapporo, 01 Hokkaido University Hospital
RECRUITING
Japan Tokyo, 13 Kyorin University Hospital
RECRUITING
Italy Bari Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
RECRUITING
Italy Campobasso Ospedale Regionale Cardarelli-Università degli Studi del Mol
RECRUITING
Italy Catanzaro Universita della Magna grecia
RECRUITING
Italy Firenze AOU Careggi
RECRUITING
Italy Napoli Azienda Ospedaliera Universitaria Federico II
RECRUITING
Italy Napoli Seconda Univesità degli Studi di Napoli, AOU
RECRUITING
Italy Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Italy Pisa Azienda Ospedaliero Universitaria Pisana
RECRUITING
Italy Potenza Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
RECRUITING
Italy Rome Universita Cattolica del Sacro Cuore
RECRUITING
Italy Rozzano Istituto Clinico Humanitas
RECRUITING
Italy Torino Azienda Ospedaliera Città della Salute e della Scienza di Torino
RECRUITING
Italy Udine Azienda Ospedaliero Universitaria S.Maria Della Misericordia
RECRUITING
Italy Verona Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Greece Athens Athens Navy Hospital
RECRUITING
Greece Athens Evangelismos General Hospital of Athens
RECRUITING
Greece Athens General Hospital 'Gennimatas'
RECRUITING
Greece Athens Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
RECRUITING
Greece Athens Laiko General Hospital of Athens
RECRUITING
Greece Ioannina University Hospital of Ioannina
RECRUITING
Greece Patra 'Agios Andreas' General Hospital of Patras
RECRUITING
Greece Patras University General Hospital of Rio Patras
RECRUITING
Greece Thessaloniki Ippokrateio Hospital
RECRUITING
Germany Amberg, BY Praxis für Rheumatologie
RECRUITING
Germany Bayreuth Rheuma-Praxis Bayreuth
RECRUITING
Germany Berlin, BE Rheumatologische Schwerpunktpraxis
RECRUITING
Germany Berlin, BE Rheumatologische Schwerpunktpraxis
RECRUITING
Germany Dusseldorf Universitätsklinikum Düsseldorf
RECRUITING
Germany Erfurt, TH Service Rheuma Erfurt
COMPLETED
Germany Frankfurt, HE Universitatsklinikum Frankfurt
RECRUITING
Germany Halle-Saale, ST Rheumapraxis Dr. Liebhaber
RECRUITING
Germany Hamburg, HH Praxis fur Klinische Studien und Praxis fur Orthopadie
RECRUITING
Germany Hamburg, HH Rheumatologie im Struenseehaus
RECRUITING
Germany Herne, NW Rheumazentrum Ruhrgebiet
RECRUITING
Germany Koln Krankenhaus Porz am Rhein
RECRUITING
Germany Leipzig Rheumatologische Praxis
RECRUITING
Germany Magdeburg Rheumatologische Praxis
RECRUITING
Germany München Praxiszentrum St. Bonifatius
COMPLETED
Germany Neubrandenburg, MV Praxis Thilo Klopsch
RECRUITING
Germany Püttlingen, SL Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
RECRUITING
Germany Ratingen Rheumazentrum Ratingen
RECRUITING
Germany Templin, BB Rheumatologisch-immunologische Arztpraxis
RECRUITING
Germany Vogelsang-Gommern, ST Immunologisches Zentrum Vogelsang-Gommern GmbH
RECRUITING
France Bobigny Hôpital Avicenne
RECRUITING
France Cholet Centre Hospitalier de Cholet
RECRUITING
France Clermont Ferrand Hôpital Gabriel Montpied
RECRUITING
France Creteil Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
RECRUITING
France Echirolles CHU Grenoble
RECRUITING
France Lille CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
RECRUITING
France Lyon Centre Orthopedique Santy
RECRUITING
France Lyon Clinique de l'Infirmerie Protestante de Lyon
RECRUITING
France Nice Hôpital Saint Roch
RECRUITING
France Orléans CHR Orléans - Nouvel Hôpital Orléans La Source
RECRUITING
France Paris Hopital Saint-Antoine
RECRUITING
France Paris Hôpital Bichat
RECRUITING
France Paris Hôpital Lariboisière - Centre Viggo Petersen
RECRUITING
France Paris Hôpital Pitié-Salpétrière
RECRUITING
France Strasbourg Cedex CHRU Hôpital de Hautepierre
RECRUITING
France Toulouse Hopital Purpan
RECRUITING
Colombia Bogota BIOMAB
RECRUITING
Colombia Bucaramanga, SAN Servimed S A S
RECRUITING
Colombia Medellin, ANT Clinisalud del Sur
RECRUITING
Colombia Montería, COR Funcentra
RECRUITING
Canada Dundas, ON Private Practice - Dr. Pauline Boulos
RECRUITING
Canada Markham, ON Markham Rheumatology Hub
RECRUITING
Canada Mississauga, ON Brandusa Florica Medicine Professional Corporation
RECRUITING
Canada Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
RECRUITING
Canada Orillia, ON The Waterside Clinic
RECRUITING
Canada Ottawa, ON The Ottawa Hospital Research Institute
RECRUITING
Canada Quebec, QC G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
RECRUITING
Canada Rimouski, QC Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
RECRUITING
Canada Saskatoon, SK Community Rheumatology Care
RECRUITING
Canada Saskatoon, SK Rheumatology Associates of Saskatoon
COMPLETED
Canada Sherbrooke, QC Centre Hospitalier Universitaire de Sherbrooke
RECRUITING
Canada Sydney, NS Riverside Professional Center
RECRUITING
Canada Trois Rivieres, QC Centre de Recherche Musculo Squelettique
RECRUITING
Canada Vancouver, BC Artus Health Centre
RECRUITING
Canada Windsor, ON Dr. Sabeen Anwar Medicine Professional Corporation
RECRUITING
Canada Winnipeg, MB Manitoba Clinic
RECRUITING
Belgium Brugge AZ Sint-Jan
RECRUITING
Belgium Brussel, BRU Hopital Erasme
RECRUITING
Belgium Genk, VLI Reumaclinic Genk-Hasselt
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
Belgium Liège CHU de Liège - Domaine Universitaire du Sart Tilman
RECRUITING
Austria Graz LKH-Univ. Klinikum Graz
RECRUITING
Austria Linz Kepler Universitätsklinikum GmbH
COMPLETED
Austria Vienna Medizinische Universitat Wien
RECRUITING
Austria Wien Evang. Krankenhaus Gemein. Betriebgesm. Mbh
COMPLETED
Australia Adelaide, SA The Queen Elizabeth Hospital
RECRUITING
Australia Footscray, VIC Footscray Hospital, Western Health
RECRUITING
Australia St Leonards, NSW Royal North Shore Hospital
RECRUITING
Argentina Buenos Aires, B Hospital Italiano de Buenos Aires
RECRUITING
Argentina Buenos Aires, B Hospital J. M. Ramos Mejía
RECRUITING
Argentina Ciudad Autónoma de Buenos Aires, B OMI
COMPLETED
Argentina Córdoba, X Hospital Cordoba
RECRUITING
Argentina San Fernando Buenos Aires MR Medicina Reumatologica
RECRUITING
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