Clinical trial NCT05049798: A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice
Official title: Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 1314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
timeFrame: Up to 39 months
measure: The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant
timeFrame: Up to 39 months
Secondary outcomes:
measure: Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Assessment of Dactylitis
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Nail Involvement
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Body Surface Area (BSA) Psoriasis (PSO) Skin Involvement
timeFrame: Baseline up to 39 months
measure: Change from Baseline in C-reactive Protein (CRP)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA/DAPSA)
timeFrame: Baseline up to 39 months
measure: Response as a Measure of Clinical Improvement in cDAPSA/DAPSA
timeFrame: Up to 39 months
measure: Start and Stop Dates of All Treatments and the Sequence of Treatment Lines
timeFrame: Up to 39 months
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to 39 months
measure: BSA PSO Skin Involvement
timeFrame: Up to 39 months
measure: Rheumatic Disease Comorbidity Index
timeFrame: Up to 39 months
measure: Change from Baseline in Fibromyalgia Rapid Screening Tool (FiRST)
timeFrame: Baseline up to 6 months
measure: Change from Baseline in European Quality of Life (EuroQoL) 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Patient Global Disease Activity Visual Analog Scale (VAS) Scores
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Pain VAS Score
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Patient Acceptable Symptom State (PASS)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI: PsA)
timeFrame: Baseline up to 39 months
measure: Change from Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
timeFrame: Baseline up to 39 months
measure: Number of Participants Switching or Stopping Treatment
timeFrame: Up to 39 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital J. M. Ramos Mejía
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: OMI
city: Córdoba
country: Argentina
facility: Hospital Cordoba
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
city: Footscray
country: Australia
facility: Footscray Hospital, Western Health
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Linz
country: Austria
facility: Kepler Universitatsklinikum GmbH
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien
city: Wien
country: Austria
facility: Evang. Krankenhaus Gemein. Betriebgesm. Mbh
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brussel
country: Belgium
facility: Hopital Erasme
city: Genk
country: Belgium
facility: Reumaclinic Genk-Hasselt
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Vancouver
country: Canada
facility: Artus Health Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Sydney
country: Canada
facility: Riverside Professional Centre
state: Nova Scotia
city: Dundas
country: Canada
facility: Private Practice - Dr. Pauline Boulos
state: Ontario
city: Markham
country: Canada
facility: Markham Rheumatology Hub
state: Ontario
city: Mississauga
country: Canada
facility: Brandusa Florica Medicine Professional Corporation
state: Ontario
city: Orillia
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Windsor
country: Canada
facility: Dr Sabeen Anwar Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
state: Quebec
city: Rimouski
country: Canada
facility: Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Trois Rivieres
country: Canada
facility: Centre de Recherche Musculo Squelettique
state: Quebec
city: Saskatoon
country: Canada
facility: Community Rheumatology Care
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Rheumatology Associates of Saskatoon
state: Saskatchewan
city: Quebec
country: Canada
facility: G R M O Groupe de recherche en maladies osseuses Inc
city: Bogota
country: Colombia
facility: BIOMAB
city: Bucaramanga
country: Colombia
facility: Servimed S A S
city: Medellin
country: Colombia
facility: Clinica Vascular las Americas
city: Medellín
country: Colombia
facility: Clinisalud del Sur
city: Montería
country: Colombia
facility: Funcentra
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Creteil
country: France
facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
city: Echirolles
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
city: Lyon
country: France
facility: Centre Orthopedique Santy
city: Lyon
country: France
facility: Clinique de l'Infirmerie Protestante de Lyon
city: Nice
country: France
facility: Hôpital Saint Roch
city: Orléans
country: France
facility: CHR Orléans - Nouvel Hôpital Orléans La Source
city: Paris
country: France
facility: Hôpital Lariboisière - Centre Viggo Petersen
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Strasbourg Cedex
country: France
facility: CHRU Hôpital de Hautepierre
city: Toulouse
country: France
facility: Hopital Purpan
city: Amberg
country: Germany
facility: Praxis für Rheumatologie
city: Bayreuth
country: Germany
facility: Rheuma-Praxis Bayreuth
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Erfurt
country: Germany
facility: Service Rheuma Erfurt
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Halle-Saale
country: Germany
facility: Rheumapraxis Dr. Liebhaber
city: Hamburg
country: Germany
facility: Praxis fur Klinische Studien und Praxis fur Orthopadie
city: Hamburg
country: Germany
facility: Rheumatologie im Struenseehaus
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Koln
country: Germany
facility: Krankenhaus Porz am Rhein
city: Leipzig
country: Germany
facility: Rheumatologische Praxis
city: Magdeburg
country: Germany
facility: Rheumatologische Praxis
city: München
country: Germany
facility: Praxiszentrum St. Bonifatius
city: Neubrandenburg
country: Germany
facility: Praxis Thilo Klopsch
city: Püttlingen
country: Germany
facility: Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Templin
country: Germany
facility: Rheumatologisch-immunologische Arztpraxis
city: Vogelsang-Gommern
country: Germany
facility: Immunologisches Zentrum Vogelsang-Gommern GmbH
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: Athens Navy Hospital
city: Athens
country: Greece
facility: General Hospital 'Gennimatas'
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Patras
country: Greece
facility: University General Hospital of Rio Patras
city: Patra
country: Greece
facility: 'Agios Andreas' General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Ippokrateio Hospital
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Campobasso
country: Italy
facility: Ospedale Regionale Cardarelli-Università degli Studi del Mol
city: Catanzaro
country: Italy
facility: Universita della Magna grecia
city: Firenze
country: Italy
facility: AOU Careggi
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: Seconda Univesità degli Studi di Napoli, AOU
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Potenza
country: Italy
facility: Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
city: Rome
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Hyogo
country: Japan
facility: Kita-harima Medical Center
city: Meguro-ku
country: Japan
facility: Toho University Medical Center, Ohashi Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Cheonan-si
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Mexico
country: Mexico
facility: Consultorio de Reumatologia
city: Zapopan
country: Mexico
facility: Hospital Puerta de Hierro
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Kemerovo
country: Russian Federation
facility: SBEU HPE Kemerovo State Medical Academy
city: Moscow
country: Russian Federation
facility: Bakoulev Scientific Center For Cardiovascular Surgery Rams
city: Moscow
country: Russian Federation
facility: FGBU Research Institute of Rheumatology named V.A.Nasonova
city: Tomsk
country: Russian Federation
facility: City Hospital #3
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Algeciras / Cadiz
country: Spain
facility: Hosp. Punta de Europa
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Granada
country: Spain
facility: Complejo hospitalario de Granada
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. de Getafe
city: Oviedo
country: Spain
facility: Hosp. Univ. Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Stockholm
country: Sweden
facility: Akademiskt Specialistcentrum centrum för reumatologi
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital Cantonal
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Aberdeen
country: United Kingdom
facility: NHS Grampian - Aberdeen Royal Infirmary (ARI)
city: Abergavenny
country: United Kingdom
facility: Nevill Hall Hospital
city: Airdrie
country: United Kingdom
facility: University Hospital Monklands
city: Barnet
country: United Kingdom
facility: Royal Free London NHS Foundation Trust Barnet Hospital
city: Bath
country: United Kingdom
facility: Wolfson Centre Royal United Hospitals
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Salford
country: United Kingdom
facility: Shirley Caldwell
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Staffordshire
country: United Kingdom
facility: Haywood Hospital
city: Stamford
country: United Kingdom
facility: Stamford and Rutland hospital
city: Wishaw
country: United Kingdom
facility: Wishaw General
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: