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

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: Recruiting
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Guselkumab; Drug: IL-17i

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: Observational
• Enrollment (Estimated): 1330

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199ABB
    • Recruiting
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina, C1221ADC
    • Recruiting
    • Hospital J. M. Ramos Mejía
  • Ciudad Autónoma de Buenos Aires, Argentina, C1015ABO
    • Completed
    • OMI
  • Córdoba, Argentina, 5000
    • Recruiting
    • Hospital Cordoba
  • San Fernando Buenos Aires, Argentina, B1646
    • Recruiting
    • MR Medicina Reumatologica
• Australia
  • Adelaide, Australia, 5011
    • Recruiting
    • The Queen Elizabeth Hospital
  • Footscray, Australia
    • Recruiting
    • Footscray Hospital, Western Health
  • St Leonards, Australia, 2065
    • Recruiting
    • Royal North Shore Hospital
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • LKH-Univ. Klinikum Graz
  • Linz, Austria, 4021
    • Completed
    • Kepler Universitätsklinikum GmbH
  • Vienna, Austria, 1090
    • Recruiting
    • Medizinische Universitat Wien
  • Wien, Austria, A-1100
    • Completed
    • Evang. Krankenhaus Gemein. Betriebgesm. Mbh
• Belgium
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
  • Brussel, Belgium, 1070
    • Recruiting
    • Hopital Erasme
  • Genk, Belgium, 3600
    • Recruiting
    • Reumaclinic Genk-Hasselt
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège - Domaine Universitaire du Sart Tilman
• Canada
  • Quebec, Canada, G1V 3M7
    • Recruiting
    • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1J9
      • Recruiting
      • Artus Health Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Recruiting
      • Manitoba Clinic
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 3N1
      • Recruiting
      • Riverside Professional Center
  • Ontario
    • Dundas, Ontario, Canada, L9H 1B7
      • Recruiting
      • Private Practice - Dr. Pauline Boulos
    • Markham, Ontario, Canada, L3R 2C7
      • Recruiting
      • Markham Rheumatology Hub
    • Mississauga, Ontario, Canada, L5A 3V8
      • Recruiting
      • Brandusa Florica Medicine Professional Corporation
    • Orillia, Ontario, Canada, L3V 1T5
      • Recruiting
      • The Waterside Clinic
    • Ottawa, Ontario, Canada, K1H 7W9
      • Recruiting
      • The Ottawa Hospital Research Institute
    • Windsor, Ontario, Canada, N8X 1T3
      • Recruiting
      • Dr. Sabeen Anwar Medicine Professional Corporation
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
    • Rimouski, Quebec, Canada, G5L 5T1
      • Recruiting
      • Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • Centre Hospitalier Universitaire de Sherbrooke
    • Trois Rivieres, Quebec, Canada, G8Z1Y2
      • Recruiting
      • Centre de Recherche Musculo Squelettique
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Recruiting
      • Community Rheumatology Care
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Completed
      • Rheumatology Associates of Saskatoon
• Colombia
  • Bogota, Colombia
    • Recruiting
    • BIOMAB
  • Bucaramanga, Colombia
    • Recruiting
    • Servimed S A S
  • Medellin, Colombia, 55422
    • Recruiting
    • Clinisalud del Sur
  • Montería, Colombia, 230002
    • Recruiting
    • Funcentra
• France
  • Bobigny, France, 93000
    • Recruiting
    • Hôpital Avicenne
  • Cholet, France, 49300
    • Recruiting
    • Centre Hospitalier de Cholet
  • Clermont Ferrand, France, 63003
    • Recruiting
    • Hôpital Gabriel Montpied
  • Creteil, France, 94000
    • Recruiting
    • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
  • Echirolles, France, 38130
    • Recruiting
    • CHU Grenoble
  • Lille, France, 59037
    • Recruiting
    • CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur
  • Lyon, France, 69300
    • Recruiting
    • Clinique de l'Infirmerie Protestante de Lyon
  • Lyon, France, 69008
    • Recruiting
    • Centre Orthopedique Santy
  • Nice, France, 6006
    • Recruiting
    • Hôpital Saint Roch
  • Orléans, France, 45032
    • Recruiting
    • CHR Orléans - Nouvel Hôpital Orléans La Source
  • Paris, France, 75012
    • Recruiting
    • Hopital Saint-Antoine
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat
  • Paris, France, 75651
    • Recruiting
    • Hôpital Pitié-Salpétrière
  • Paris, France, 75010
    • Recruiting
    • Hôpital Lariboisière - Centre Viggo Petersen
  • Strasbourg Cedex, France, 67098
    • Recruiting
    • CHRU Hôpital de Hautepierre
  • Toulouse, France, 31059
    • Recruiting
    • Hopital Purpan
• Germany
  • Amberg, Germany, 92224
    • Recruiting
    • Praxis für Rheumatologie
  • Bayreuth, Germany, 95444
    • Recruiting
    • Rheuma-Praxis Bayreuth
  • Berlin, Germany, 12161
    • Recruiting
    • Rheumatologische Schwerpunktpraxis
  • Berlin, Germany, 13055
    • Recruiting
    • Rheumatologische Schwerpunktpraxis
  • Dusseldorf, Germany, 40225
    • Recruiting
    • Universitätsklinikum Düsseldorf
  • Erfurt, Germany, 99096
    • Completed
    • Service Rheuma Erfurt
  • Frankfurt, Germany, 60590
    • Recruiting
    • Universitatsklinikum Frankfurt
  • Halle-Saale, Germany, 6128
    • Recruiting
    • Rheumapraxis Dr. Liebhaber
  • Hamburg, Germany, 22767
    • Recruiting
    • Rheumatologie im Struenseehaus
  • Hamburg, Germany, 22415
    • Recruiting
    • Praxis fur Klinische Studien und Praxis fur Orthopadie
  • Herne, Germany, 44649
    • Recruiting
    • Rheumazentrum Ruhrgebiet
  • Koln, Germany, 51149
    • Recruiting
    • Krankenhaus Porz am Rhein
  • Leipzig, Germany, 04109
    • Recruiting
    • Rheumatologische Praxis
  • Magdeburg, Germany, 39104
    • Recruiting
    • Rheumatologische Praxis
  • München, Germany, 81541
    • Completed
    • Praxiszentrum St. Bonifatius
  • Neubrandenburg, Germany, 17033
    • Recruiting
    • Praxis Thilo Klopsch
  • Püttlingen, Germany, 66346
    • Recruiting
    • Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie
  • Ratingen, Germany, 40878
    • Recruiting
    • Rheumazentrum Ratingen
  • Templin, Germany, 17268
    • Recruiting
    • Rheumatologisch-immunologische Arztpraxis
  • Vogelsang-Gommern, Germany, 39245
    • Recruiting
    • Immunologisches Zentrum Vogelsang-Gommern GmbH
• Greece
  • Athens, Greece, 10676
    • Recruiting
    • Evangelismos General Hospital of Athens
  • Athens, Greece, 11527
    • Recruiting
    • Laiko General Hospital of Athens
  • Athens, Greece, 11527
    • Recruiting
    • General Hospital 'Gennimatas'
  • Athens, Greece, 11521
    • Recruiting
    • Athens Navy Hospital
  • Athens, Greece, 11527
    • Recruiting
    • Hippokration General Hospital of Athens, B' Internal Medicine Clinic,
  • Ioannina, Greece, 45560
    • Recruiting
    • University Hospital of Ioannina
  • Patra, Greece, 263 32
    • Recruiting
    • 'Agios Andreas' General Hospital of Patras
  • Patras, Greece, 26500
    • Recruiting
    • University General Hospital of Rio Patras
  • Thessaloniki, Greece, 546 42
    • Recruiting
    • Ippokrateio Hospital
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  • Campobasso, Italy, 86100
    • Recruiting
    • Ospedale Regionale Cardarelli-Università degli Studi del Mol
  • Catanzaro, Italy, 88100
    • Recruiting
    • Universita della Magna grecia
  • Firenze, Italy, 50141
    • Recruiting
    • AOU Careggi
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria Federico II
  • Napoli, Italy, 80131
    • Recruiting
    • Seconda Univesità degli Studi di Napoli, AOU
  • Palermo, Italy, 90127
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
  • Potenza, Italy, 85100
    • Recruiting
    • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
  • Rome, Italy, 20123
    • Recruiting
    • Universita Cattolica del Sacro Cuore
  • Rozzano, Italy, 20156
    • Recruiting
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Recruiting
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Udine, Italy, 33100
    • Recruiting
    • Azienda Ospedaliero Universitaria S.Maria Della Misericordia
  • Verona, Italy, 37067
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Hyogo, Japan, 6751392
    • Recruiting
    • Kita-harima Medical Center
  • Meguro-ku, Japan, 153-8515
    • Recruiting
    • Toho University Medical Center, Ohashi Hospital
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 550 0006
    • Recruiting
    • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
  • Sapporo, Japan, 060-8648
    • Recruiting
    • Hokkaido University Hospital
  • Tokyo, Japan, 181 8611
    • Recruiting
    • Kyorin University Hospital
• Korea, Republic of
  • Cheonan-si, Korea, Republic of, 31151
    • Recruiting
    • Soonchunhyang University Cheonan Hospital
  • Seongnam, Korea, Republic of, 13620
    • Completed
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 07061
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
• Mexico
  • Merida, Mexico, 97070
    • Recruiting
    • Medical Care & Research SA de CV
  • Mexico, Mexico, 07760
    • Recruiting
    • Consultorio de Reumatologia
  • Zapopan, Mexico, 45116
    • Recruiting
    • Hospital Puerta de Hierro
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Academisch Medisch Centrum Universiteit van Amsterdam
  • Enschede, Netherlands, 7500 KA
    • Recruiting
    • Medisch Spectrum Twente
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • Universitair Medisch Centrum Groningen
  • Helmond, Netherlands, 5707 HA
    • Recruiting
    • Elkerliek Ziekenhuis
• Russian Federation
  • Kemerovo, Russian Federation, G4 0SF
    • Terminated
    • SBEU HPE Kemerovo State Medical Academy
  • Moscow, Russian Federation, 121552
    • Terminated
    • Bakoulev Scientific Center For Cardiovascular Surgery Rams
  • Moscow, Russian Federation, 190068
    • Completed
    • FGBU Research Institute of Rheumatology named V.A.Nasonova
  • Tomsk, Russian Federation, 634045
    • Terminated
    • City Hospital #3
• Spain
  • A Coruna, Spain, 15006
    • Recruiting
    • Hosp. Univ. A Coruna
  • Algeciras / Cadiz, Spain, 11207
    • Recruiting
    • Hosp. Punta de Europa
  • Barcelona, Spain, 8035
    • Recruiting
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp. Clinic de Barcelona
  • Bilbao, Spain, 48013
    • Recruiting
    • Hosp. Univ. de Basurto
  • Cordoba, Spain, 14004
    • Recruiting
    • Hosp. Reina Sofia
  • Granada, Spain, 18016
    • Recruiting
    • Complejo hospitalario de Granada
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28905
    • Recruiting
    • Hosp. Univ. de Getafe
  • Oviedo, Spain, 33011
    • Recruiting
    • Hosp. Univ. Central de Asturias
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
  • Sevilla, Spain, 41013
    • Recruiting
    • Hosp. Virgen Del Rocio
• Sweden
  • Göteborg, Sweden, 416 85
    • Recruiting
    • Sahlgrenska Universitetssjukhuset
  • Lund, Sweden, 221 00
    • Recruiting
    • Universitetssjukhuset i Lund
  • Orebro, Sweden, 70185
    • Recruiting
    • Universitetssjukhuset Orebro
  • Stockholm, Sweden, 113 65
    • Recruiting
    • Akademiskt Specialistcentrum centrum för reumatologi
  • Uppsala, Sweden, 75185
    • Recruiting
    • Akademiska Sjukhuset
• Switzerland
  • Fribourg, Switzerland, 1708
    • Recruiting
    • HFR Fribourg - Hôpital Cantonal
• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Recruiting
    • Kaohsiung Veterans General Hospital
  • Kaohsiung, Taiwan, 83301
    • Recruiting
    • Chang Gung Medical Foundation
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZB
    • Recruiting
    • NHS Grampian - Aberdeen Royal Infirmary (ARI)
  • Abergavenny, United Kingdom, NP7 7EG
    • Recruiting
    • Nevill Hall Hospital
  • Airdrie, United Kingdom, ML6 0JS
    • Recruiting
    • University Hospital Monklands
  • Bath, United Kingdom, BA1 3NG
    • Recruiting
    • Wolfson Centre Royal United Hospitals
  • Glasgow, United Kingdom, 650029
    • Recruiting
    • Glasgow Royal Infirmary
  • Hull, United Kingdom, HU3 2JZ
    • Recruiting
    • Hull Royal Infirmary
  • Leeds, United Kingdom, LS7 4SA
    • Recruiting
    • Chapel Allerton Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • Kings College Hospital
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Central Manchester University Hospitals NHS Foundation Trust
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
  • Portsmouth, United Kingdom, PO6 3LY
    • Recruiting
    • Queen Alexandra Hospital
  • Salford, United Kingdom, M6 8HD
    • Recruiting
    • Shirley Caldwell
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital
  • Staffordshire, United Kingdom, ST6 7AG
    • Recruiting
    • Haywood Hospital
  • Stamford, United Kingdom, PE9 1UA
    • Recruiting
    • Stamford and Rutland hospital
  • Wishaw, United Kingdom, ML2 0DP
    • Recruiting
    • Wishaw General

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively	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)	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	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)	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	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	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)	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)	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)	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	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	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)	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	The BSA score indicates the surface area of the participant's body affected by psoriasis.	Up to 39 months
Rheumatic Disease Comorbidity Index	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)	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)	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)	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)	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	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	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)	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)	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)	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)	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)	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)	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	Number of Participants switching or stopping treatment (including reasons for discontinuation) will be reported.	Up to 39 months

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Investigators: Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

General Publications

• Girdauskas E, Pausch J, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Krane M, Vitanova K, Borger M, Eden M, Hachaturyan V, Bramlage P, Falk V. Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. J Cardiothorac Surg. 2022 Dec 30;17(1):343. doi: 10.1186/s13019-022-02045-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 7, 2027

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CR108938; CNTO1959PSA4001 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

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