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

June 4, 2026 updated by: Janssen Pharmaceutica N.V., Belgium

Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1221ADC
        • Hospital J. M. Ramos Mejía
      • Buenos Aires, Argentina, C1015ABO
        • OMI
      • Córdoba, Argentina, 5000
        • Hospital Cordoba
      • San Fernando, Argentina, B1646
        • MR Medicina Reumatologica
  • Australia
      • Adelaide, Australia, 5011
        • The Queen Elizabeth Hospital
      • Footscray, Australia
        • Footscray Hospital, Western Health
      • St Leonards, Australia, 2065
        • Royal North Shore Hospital
  • Austria
      • Graz, Austria, 8036
        • LKH-Univ. Klinikum Graz
      • Linz, Austria, 4021
        • Kepler Universitatsklinikum GmbH
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien
      • Vienna, Austria, A-1100
        • Evang. Krankenhaus Gemein. Betriebgesm. Mbh
  • Belgium
      • Bruges, Belgium, 8000
        • AZ Sint-Jan
      • Brussels, Belgium, 1070
        • Hôpital Erasme
      • Genk, Belgium, 3600
        • Reumaclinic Genk-Hasselt
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1J9
        • Artus Health Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • St. Claire's Mercy Hospital - Rheumatology Research
    • Nova Scotia
      • Coxheath, Nova Scotia, Canada, B1L 1B3
        • Dr. Juris Lazovskis Incorporated
    • Ontario
      • Dundas, Ontario, Canada, L9H 1B7
        • Private Practice - Dr. Pauline Boulos
      • Markham, Ontario, Canada, L3R 2C7
        • Markham Rheumatology Hub
      • Mississauga, Ontario, Canada, L5A 3V8
        • Brandusa Florica Medicine Professional Corporation
      • Orillia, Ontario, Canada, L3V 1T5
        • The Waterside Clinic
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital Research Institute
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr Sabeen Anwar Medicine Professional Corporation
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
      • Québec, Quebec, Canada, G1V 3M7
        • G R M O Groupe de recherche en maladies osseuses Inc
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
      • Trois-Rivières, Quebec, Canada, G9A 3X2
        • Centre de Recherche Musculo Squelettique
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Community Rheumatology Care
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Rheumatology Associates of Saskatoon
  • Colombia
      • Bogotá, Colombia
        • BIOMAB
      • Bucaramanga, Colombia
        • Servimed S A S
      • Medellín, Colombia, 50012
        • Clinisalud del Sur
      • Medellín, Colombia, 50025
        • Clinica Vascular las Americas
      • Montería, Colombia, 230002
        • Funcentra
  • France
      • Bobigny, France, 93000
        • Hopital Avicenne
      • Cholet, France, 49300
        • Centre Hospitalier de Cholet
      • Clermont-Ferrand, France, 63003
        • Hôpital Gabriel Montpied
      • Créteil, France, 94000
        • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
      • Lille, France, 59037
        • CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
      • Lyon, France, 69008
        • Centre Orthopedique Santy
      • Lyon, France, 69300
        • Clinique de l'Infirmerie Protestante de Lyon
      • Nice, France, 6006
        • Hôpital Saint Roch
      • Orléans, France, 45032
        • CHR Orléans - Nouvel Hôpital Orléans La Source
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75651
        • Hôpital Pitié Salpêtrière
      • Paris, France, 75018
        • Hôpital Bichat
      • Paris, France, 75010
        • Hôpital Lariboisière - Centre Viggo Petersen
      • Strasbourg, France, 67098
        • CHRU Hôpital de Hautepierre
      • Toulouse, France, 31059
        • Hopital Purpan
      • Échirolles, France, 38130
        • CHU Grenoble
  • Germany
      • Amberg, Germany, 92224
        • Praxis für Rheumatologie
      • Bayreuth, Germany, 95444
        • Rheuma-Praxis Bayreuth
      • Berlin, Germany, 12161
        • Rheumatologische Schwerpunktpraxis
      • Berlin, Germany, 13055
        • Rheumatologische Schwerpunktpraxis 1
      • Cologne, Germany, 51149
        • Krankenhaus Porz am Rhein
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Erfurt, Germany, 99096
        • Service Rheuma Erfurt
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Halle, Germany, 6128
        • Rheumapraxis Dr. Liebhaber
      • Hamburg, Germany, 22767
        • Rheumatologie im Struenseehaus
      • Hamburg, Germany, 22415
        • Praxis fur Klinische Studien und Praxis fur Orthopadie
      • Herne, Germany, 44649
        • Rheumazentrum Ruhrgebiet
      • Leipzig, Germany, 04109
        • Rheumatologische Praxis 1
      • Magdeburg, Germany, 39104
        • Rheumatologische Praxis
      • München, Germany, 81541
        • Praxiszentrum St. Bonifatius
      • Neubrandenburg, Germany, 17033
        • Praxis Thilo Klopsch
      • Püttlingen, Germany, 66346
        • Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
      • Ratingen, Germany, 40878
        • Rheumazentrum Ratingen
      • Templin, Germany, 17268
        • Rheumatologisch-immunologische Arztpraxis
      • Vogelsang-Gommern, Germany, 39245
        • Immunologisches Zentrum Vogelsang-Gommern GmbH
  • Greece
      • Athens, Greece, 10676
        • Evangelismos General Hospital of Athens
      • Athens, Greece, 11527
        • Laiko General Hospital of Athens
      • Athens, Greece, 11521
        • Athens Navy Hospital
      • Athens, Greece, 11527
        • General Hospital 'Gennimatas'
      • Athens, Greece, 11527
        • Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
      • Ioannina, Greece, 45560
        • University Hospital of Ioannina
      • Pátrai, Greece, 263 32
        • 'Agios Andreas' General Hospital of Patras
      • Pátrai, Greece, 26500
        • University General Hospital of Rio Patras
      • Thessaloniki, Greece, 546 42
        • Ippokrateio Hospital
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Campobasso, Italy, 86100
        • Ospedale Regionale Cardarelli-Università degli Studi del Mol
      • Catanzaro, Italy, 88100
        • Universita della Magna grecia
      • Florence, Italy, 50141
        • AOU Careggi
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Naples, Italy, 80131
        • Seconda Univesità degli Studi di Napoli, AOU
      • Palermo, Italy, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Potenza, Italy, 85100
        • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
      • Rome, Italy, 20123
        • Universita Cattolica del Sacro Cuore
      • Rozzano, Italy, 20156
        • Istituto Clinico Humanitas
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Udine, Italy, 33100
        • Azienda Ospedaliero Universitaria S.Maria Della Misericordia
      • Verona, Italy, 37067
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Japan
      • Hyōgo, Japan, 6751392
        • Kita-harima Medical Center
      • Meguro-ku, Japan, 153-8515
        • Toho University Medical Center, Ohashi Hospital
      • Osaka, Japan, 545 8586
        • Osaka Metropolitan University Hospital
      • Osaka, Japan, 550 0006
        • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Tokyo, Japan, 181 8611
        • Kyorin University Hospital
  • Mexico
      • Mérida, Mexico, 97070
        • Medical Care & Research SA de CV
      • México, Mexico, 07760
        • Consultorio de Reumatologia
      • Zapopan, Mexico, 45116
        • Hospital Puerta de Hierro
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum Universiteit van Amsterdam
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Groningen, Netherlands, 9700 RB
        • Universitair Medisch Centrum Groningen
      • Helmond, Netherlands, 5707 HA
        • Elkerliek Ziekenhuis
  • Russia
      • Kemerovo, Russia, G4 0SF
        • SBEU HPE Kemerovo State Medical Academy
      • Moscow, Russia, 121552
        • Bakoulev Scientific Center For Cardiovascular Surgery Rams
      • Moscow, Russia, 190068
        • FGBU Research Institute of Rheumatology named V.A.Nasonova
      • Tomsk, Russia, 634045
        • City Hospital #3
  • South Korea
      • Cheonan-si, South Korea, 31151
        • Soonchunhyang University Cheonan Hospital
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Spain
      • A Coruña, Spain, 15006
        • Hosp Univ A Coruna
      • Algeciras / Cadiz, Spain, 11207
        • Hosp. Punta de Europa
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hosp Univ Vall D Hebron
      • Bilbao, Spain, 48013
        • Hosp. Univ. de Basurto
      • Córdoba, Spain, 14004
        • Hosp Reina Sofia
      • Granada, Spain, 18016
        • Complejo hospitalario de Granada
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28905
        • Hosp. Univ. de Getafe
      • Oviedo, Spain, 33011
        • Hosp. Univ. Central de Asturias
      • Santiago de Compostela, Spain, 15706
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spain, 41013
        • Hosp. Virgen Del Rocio
  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska Universitetssjukhuset
      • Malmö, Sweden, 20502
        • Universitetssjukhuset i Lund
      • Stockholm, Sweden, 113 65
        • Akademiskt Specialistcentrum centrum för reumatologi
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
      • Örebro, Sweden, 70185
        • Universitetssjukhuset Örebro
  • Switzerland
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hôpital Cantonal
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZB
        • NHS Grampian - Aberdeen Royal Infirmary (ARI)
      • Abergavenny, United Kingdom, NP7 7EG
        • Nevill Hall Hospital
      • Airdrie, United Kingdom, ML6 0JS
        • University Hospital Monklands
      • Barnet, United Kingdom, EN5 3DJ
        • Royal Free London NHS Foundation Trust Barnet Hospital
      • Bath, United Kingdom, BA1 3NG
        • Wolfson Centre Royal United Hospitals
      • Glasgow, United Kingdom, 650029
        • Glasgow Royal Infirmary
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS7 4SA
        • Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Salford, United Kingdom, M6 8HD
        • Shirley Caldwell
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Staffordshire, United Kingdom, ST6 7AG
        • Haywood Hospital
      • Stamford, United Kingdom, PE9 1UA
        • Stamford and Rutland hospital
      • Wishaw, United Kingdom, ML2 0DP
        • Wishaw General

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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.
Other Names:
  • TREMFYA
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
Time Frame: Up to 39 months
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
Time Frame: Up to 39 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively
Time Frame: Baseline up to 39 months
Change from baseline in 66 and 68 joint counts for swelling and tenderness, respectively will be reported. Joints assessed include the distal interphalangeal, proximal interphalangeal, and metacarpophalangeal joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and proximal interphalangeal joints of the feet.
Baseline up to 39 months
Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)
Time Frame: Baseline up to 39 months
The PGA-PsA will be documented using a Visual Analogue Scale (VAS) that ranges from "no PsA activity" (0 Millimeter [mm]) to "extremely active PsA" (100 mm).
Baseline up to 39 months
Change from Baseline in Assessment of Dactylitis
Time Frame: Baseline up to 39 months
The presence of and total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be documented.
Baseline up to 39 months
Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)
Time Frame: Baseline up to 39 months
The presence and a score of enthesitis will be documented using the LEI to evaluate the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: the lateral epicondyles (left and right), medial femoral condyles (left and right), and Achilles tendon insertions (left and right).
Baseline up to 39 months
Change from Baseline in Nail Involvement
Time Frame: Baseline up to 39 months
Nail involvement will be documented by recording the total number of nails of the hands and feet (that is, 0 to 20) with psoriatic nail changes.
Baseline up to 39 months
Change from Baseline in Body Surface Area (BSA) Psoriasis (PSO) Skin Involvement
Time Frame: Baseline up to 39 months
The BSA score indicates the surface area of the participant's body effected by psoriasis.
Baseline up to 39 months
Change from Baseline in C-reactive Protein (CRP)
Time Frame: Baseline up to 39 months
Change from baseline in CRP will be reported.
Baseline up to 39 months
Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)
Time Frame: Baseline up to 39 months
Change from Baseline in MDA/VLDA will be reported.
Baseline up to 39 months
Change from Baseline in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA/DAPSA)
Time Frame: Baseline up to 39 months
DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS (in centimeters), 66 and 68 joint counts for swelling and tenderness, respectively.
Baseline up to 39 months
Response as a Measure of Clinical Improvement in cDAPSA/DAPSA
Time Frame: Up to 39 months
Response is defined as a clinical improvement in cDAPSA/DAPSA. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS (in centimeters), 66 and 68 joint counts for swelling and tenderness, respectively.
Up to 39 months
Start and Stop Dates of All Treatments and the Sequence of Treatment Lines
Time Frame: Up to 39 months
Start and stop dates of all treatments and the sequence of treatment lines will be reported.
Up to 39 months
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to 39 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 39 months
BSA PSO Skin Involvement
Time Frame: Up to 39 months
The BSA score indicates the surface area of the participant's body affected by psoriasis.
Up to 39 months
Rheumatic Disease Comorbidity Index
Time Frame: Up to 39 months
Number of comorbid medical conditions of the study participants for the Rheumatic Disease Comorbidity Index will be reported.
Up to 39 months
Change from Baseline in Fibromyalgia Rapid Screening Tool (FiRST)
Time Frame: Baseline up to 6 months
FiRST will be used to help determine whether participants have chronic widespread pain or fibromyalgia syndrome at entry into the study. The FiRST is a validated questionnaire consisting of a combination of 6 items that can detect chronic widespread pain.
Baseline up to 6 months
Change from Baseline in European Quality of Life (EuroQoL) 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L)
Time Frame: Baseline up to 39 months
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems.
Baseline up to 39 months
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame: Baseline up to 39 months
The functional status of the participants will be assessed by the HAQ-DI. This 20-question self-administered instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area.
Baseline up to 39 months
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12)
Time Frame: Baseline up to 39 months
PsAID-12 is a validated, self-administered questionnaire that assesses the impact of PsA on participants' lives. It consists of 12 questions, each answered using a numerical rating scale. Questions related to pain, skin problems, work and/or leisure activities, discomfort, embarrassment and/or shame, social participation, and anger, fear, and uncertainty, and depression are scored from 0 (none) to 10 (extreme), functional capacity and sleep disturbance are scored from 0 (no difficulty) to 10 (extreme difficulty) and coping is scored from 0 (very well) to 10 (very poorly).
Baseline up to 39 months
Change from Baseline in Patient Global Disease Activity Visual Analog Scale (VAS) Scores
Time Frame: Baseline up to 39 months
The Patient Global Disease Activity VAS is a self-administered assessment with scores ranging from "very well" (0 mm) to "very poor" (100 mm) that assesses disease activity over the past week.
Baseline up to 39 months
Change from Baseline in Pain VAS Score
Time Frame: Baseline up to 39 months
The pain VAS is a self-administered assessment of average pain during the past week. The scale ranges from "no pain" (0 mm) to "the worst possible pain" (100 mm).
Baseline up to 39 months
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline up to 39 months
BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem) which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, morning stiffness severity.
Baseline up to 39 months
Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP)
Time Frame: Baseline up to 39 months
The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the CRP value.
Baseline up to 39 months
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time Frame: Baseline up to 39 months
The DLQI is a dermatology-specific, validated, 10-question quality of life instrument used to measure the impact of skin disease on the quality of life of an affected person. Each question will address how much the participant's skin problem has affected their life and is scored as: 3 = very much, 2 = a lot, 1 = a little, 0 = not at all, or not relevant.
Baseline up to 39 months
Change from Baseline in Patient Acceptable Symptom State (PASS)
Time Frame: Baseline up to 39 months
The PASS measures the level of symptoms beyond which participants consider themselves well. The PASS addresses the concepts of low disease activity, partial remission in symptoms, and well-being.
Baseline up to 39 months
Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI: PsA)
Time Frame: Baseline up to 39 months
The WPAI: PsA is a validated, self-administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI: PsA produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI: PsA outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Baseline up to 39 months
Change from Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
Time Frame: Baseline up to 39 months
TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and side effects of the medication.
Baseline up to 39 months
Number of Participants Switching or Stopping Treatment
Time Frame: Up to 39 months
Number of Participants switching or stopping treatment (including reasons for discontinuation) will be reported.
Up to 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutica N.V., Belgium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108938
  • CNTO1959PSA4001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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