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Arthritis, PsoriaticPsABIOndNCT05049798

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

An observational study of Arthritis, Psoriatic, run by Janssen Pharmaceutica N.V., Belgium at 155 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Guselkumab and IL-17i
How many people
1,314 participants
Where
155 sitesin 20 countries
Study dates
25 Aug 2021to 2 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

155 sites in 20 countries.

155 sites in 20 countries

Germany20 sites

  • Praxis für Rheumatologie

    Amberg, 92224

  • Rheuma-Praxis Bayreuth

    Bayreuth, 95444

  • Rheumatologische Schwerpunktpraxis

    Berlin, 12161

  • Rheumatologische Schwerpunktpraxis 1

    Berlin, 13055

  • Krankenhaus Porz am Rhein

    Cologne, 51149

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Service Rheuma Erfurt

    Erfurt, 99096

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Rheumapraxis Dr. Liebhaber

    Halle, 6128

  • Praxis fur Klinische Studien und Praxis fur Orthopadie

    Hamburg, 22415

  • Rheumatologie im Struenseehaus

    Hamburg, 22767

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Rheumatologische Praxis 1

    Leipzig, 04109

  • Rheumatologische Praxis

    Magdeburg, 39104

  • Praxiszentrum St. Bonifatius

    München, 81541

  • Praxis Thilo Klopsch

    Neubrandenburg, 17033

  • Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie

    Püttlingen, 66346

  • Rheumazentrum Ratingen

    Ratingen, 40878

  • Rheumatologisch-immunologische Arztpraxis

    Templin, 17268

  • Immunologisches Zentrum Vogelsang-Gommern GmbH

    Vogelsang-Gommern, 39245

Other trials in Germany

Canada16 sites

  • Dr. Juris Lazovskis Incorporated

    Coxheath, Nova Scotia, B1L 1B3

  • Private Practice - Dr. Pauline Boulos

    Dundas, Ontario, L9H 1B7

  • Markham Rheumatology Hub

    Markham, Ontario, L3R 2C7

  • Brandusa Florica Medicine Professional Corporation

    Mississauga, Ontario, L5A 3V8

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • The Waterside Clinic

    Orillia, Ontario, L3V 1T5

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 7W9

  • G R M O Groupe de recherche en maladies osseuses Inc

    Québec, Quebec, G1V 4K5

  • Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski

    Rimouski, Quebec, G5L 5T1

  • Community Rheumatology Care

    Saskatoon, Saskatchewan, S7K 0H6

  • Rheumatology Associates of Saskatoon

    Saskatoon, Saskatchewan, S7K 0H6

  • St. Claire's Mercy Hospital - Rheumatology Research

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Centre de Recherche Musculo Squelettique

    Trois-Rivières, Quebec, G9A 3X2

  • Artus Health Centre

    Vancouver, British Columbia, V5Z 1J9

  • Dr Sabeen Anwar Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

France16 sites

  • Hôpital Avicenne

    Bobigny, 93000

  • Centre Hospitalier de Cholet

    Cholet, 49300

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

    Créteil, 94000

  • CHU Grenoble

    Échirolles, 38130

  • CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur

    Lille, 59037

  • Centre Orthopedique Santy

    Lyon, 69008

  • Clinique de l'Infirmerie Protestante de Lyon

    Lyon, 69300

  • Hôpital Saint Roch

    Nice, 6006

  • CHR Orléans - Nouvel Hôpital Orléans La Source

    Orléans, 45032

  • Hôpital Lariboisière - Centre Viggo Petersen

    Paris, 75010

  • Hopital Saint-Antoine

    Paris, 75012

  • Hôpital Bichat

    Paris, 75018

  • Hopital Pitie Salpetriere

    Paris, 75651

  • CHRU Hôpital de Hautepierre

    Strasbourg, 67098

  • Hopital Purpan

    Toulouse, 31059

Other trials in France

United Kingdom16 sites

  • NHS Grampian - Aberdeen Royal Infirmary (ARI)

    Aberdeen, AB25 2ZB

  • Nevill Hall Hospital

    Abergavenny, NP7 7EG

  • University Hospital Monklands

    Airdrie, ML6 0JS

  • Royal Free London NHS Foundation Trust Barnet Hospital

    Barnet, EN5 3DJ

  • Wolfson Centre Royal United Hospitals

    Bath, BA1 3NG

  • Glasgow Royal Infirmary

    Glasgow, 650029

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Leeds Teaching Hospitals NHS Trust Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester, M13 9WL

  • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

    Newcastle upon Tyne, NE7 7DN

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Shirley Caldwell

    Salford, M6 8HD

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Haywood Hospital

    Staffordshire, ST6 7AG

  • Stamford and Rutland hospital

    Stamford, PE9 1UA

  • Wishaw General

    Wishaw, ML2 0DP

Other trials in United Kingdom

Italy14 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Ospedale Regionale Cardarelli-Università degli Studi del Mol

    Campobasso, 86100

  • Universita della Magna grecia

    Catanzaro, 88100

  • AOU Careggi

    Florence, 50141

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Seconda Univesità degli Studi di Napoli, AOU

    Naples, 80131

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

    Potenza, 85100

  • Universita Cattolica del Sacro Cuore

    Rome, 20123

  • Istituto Clinico Humanitas

    Rozzano, 20156

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ospedaliero Universitaria S.Maria Della Misericordia

    Udine, 33100

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37067

Other trials in Italy

Spain12 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Punta de Europa

    Algeciras / Cadiz, 11207

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. de Basurto

    Bilbao, 48013

  • Hosp Reina Sofia

    Córdoba, 14004

  • Complejo hospitalario de Granada

    Granada, 18016

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. de Getafe

    Madrid, 28905

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Greece9 sites

  • Evangelismos General Hospital of Athens

    Athens, 10676

  • Athens Navy Hospital

    Athens, 11521

  • General Hospital 'Gennimatas'

    Athens, 11527

  • Hippokration General Hospital of Athens, B' Internal Medicine Clinic,

    Athens, 11527

  • Laiko General Hospital of Athens

    Athens, 11527

  • University Hospital of Ioannina

    Ioannina, 45560

  • 'Agios Andreas' General Hospital of Patras

    Pátrai, 263 32

  • University General Hospital of Rio Patras

    Pátrai, 26500

  • Ippokrateio Hospital

    Thessaloniki, 546 42

Other trials in Greece

Japan6 sites

  • Kita-harima Medical Center

    Hyōgo, 6751392

  • Toho University Medical Center, Ohashi Hospital

    Meguro-ku, 153-8515

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586

  • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

    Osaka, 550 0006

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Kyorin University Hospital

    Tokyo, 181 8611

Other trials in Japan

Argentina5 sites

  • OMI

    Buenos Aires, C1015ABO

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Hospital J. M. Ramos Mejía

    Buenos Aires, C1221ADC

  • Hospital Cordoba

    Córdoba, 5000

  • MR Medicina Reumatologica

    San Fernando, B1646

Other trials in Argentina

Belgium5 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Hopital Erasme

    Brussels, 1070

  • Reumaclinic Genk-Hasselt

    Genk, 3600

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

Other trials in Belgium

Colombia5 sites

  • BIOMAB

    Bogotá

  • Servimed S A S

    Bucaramanga

  • Clinisalud del Sur

    Medellín, 50012

  • Clinica Vascular las Americas

    Medellín, 50025

  • Funcentra

    Montería, 230002

Other trials in Colombia

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345

  • Universitetssjukhuset i Lund

    Malmö, 20502

  • Universitetssjukhuset Orebro

    Örebro, 70185

  • Akademiskt Specialistcentrum centrum för reumatologi

    Stockholm, 113 65

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Austria4 sites

  • LKH-Univ. Klinikum Graz

    Graz, 8036

  • Kepler Universitatsklinikum GmbH

    Linz, 4021

  • Medizinische Universitaet Wien

    Vienna, 1090

  • Evang. Krankenhaus Gemein. Betriebgesm. Mbh

    Vienna, A-1100

Other trials in Austria

Netherlands4 sites

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Elkerliek Ziekenhuis

    Helmond, 5707 HA

Other trials in Netherlands

Russia4 sites

  • SBEU HPE Kemerovo State Medical Academy

    Kemerovo, G4 0SF

  • Bakoulev Scientific Center For Cardiovascular Surgery Rams

    Moscow, 121552

  • FGBU Research Institute of Rheumatology named V.A.Nasonova

    Moscow, 190068

  • City Hospital #3

    Tomsk, 634045

Other trials in Russia

South Korea4 sites

  • Soonchunhyang University Cheonan Hospital

    Cheonan-si, 31151

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

Australia3 sites

  • The Queen Elizabeth Hospital

    Adelaide, 5011

  • Footscray Hospital, Western Health

    Footscray

  • Royal North Shore Hospital

    St Leonards, 2065

Other trials in Australia

Mexico3 sites

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Consultorio de Reumatologia

    México, 07760

  • Hospital Puerta de Hierro

    Zapopan, 45116

Other trials in Mexico

Taiwan3 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Chang Gung Medical Foundation

    Kaohsiung City, 83301

  • Taichung Veterans General Hospital

    Taichung

Other trials in Taiwan

Switzerland1 site

  • HFR Fribourg - Hôpital Cantonal

    Fribourg, 1708

Other trials in Switzerland

About this study

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

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).

Read the 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.

Being tested
Guselkumab, IL-17i
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called TREMFYA

    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.

  • IL-17iDrug

    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.

Study groups in NCT05049798
Study groupRoleWhat they receive
Cohort 1: GuselkumabData 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.
Receives: Drug: Guselkumab
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.
Receives: Drug: IL-17i

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 39 months

  2. 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.

    Measured: Up to 39 months

Secondary outcomes (27)

  1. 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.

    Measured: Baseline up to 39 months

  2. 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).

    Measured: Baseline up to 39 months

  3. 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.

    Measured: Baseline up to 39 months

  4. 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).

    Measured: Baseline up to 39 months

  5. 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.

    Measured: Baseline up to 39 months

  6. 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.

    Measured: Baseline up to 39 months

  7. Change from Baseline in C-reactive Protein (CRP)

    Change from baseline in CRP will be reported.

    Measured: Baseline up to 39 months

  8. Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)

    Change from Baseline in MDA/VLDA will be reported.

    Measured: Baseline up to 39 months

  9. 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.

    Measured: Baseline up to 39 months

  10. 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.

    Measured: Up to 39 months

  11. 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.

    Measured: Up to 39 months

  12. 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.

    Measured: Up to 39 months

  13. BSA PSO Skin Involvement

    The BSA score indicates the surface area of the participant's body affected by psoriasis.

    Measured: Up to 39 months

  14. Rheumatic Disease Comorbidity Index

    Number of comorbid medical conditions of the study participants for the Rheumatic Disease Comorbidity Index will be reported.

    Measured: Up to 39 months

  15. 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.

    Measured: Baseline up to 6 months

  16. 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.

    Measured: Baseline up to 39 months

  17. 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.

    Measured: Baseline up to 39 months

  18. 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).

    Measured: Baseline up to 39 months

  19. 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.

    Measured: Baseline up to 39 months

  20. 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).

    Measured: Baseline up to 39 months

  21. 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.

    Measured: Baseline up to 39 months

  22. 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.

    Measured: Baseline up to 39 months

  23. 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.

    Measured: Baseline up to 39 months

  24. 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.

    Measured: Baseline up to 39 months

  25. 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.

    Measured: Baseline up to 39 months

  26. 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.

    Measured: Baseline up to 39 months

  27. Number of Participants Switching or Stopping Treatment

    Number of Participants switching or stopping treatment (including reasons for discontinuation) will be reported.

    Measured: Up to 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start25 Aug 2021
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion2 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049798
Sponsor's protocol ID
CR108938
Other IDs
CNTO1959PSA4001
Acronym
PsABIOnd
Status last verified
Nov 2026
First submitted
31 Aug 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Siebert S, Behrens F, Lubrano E, Martin N, Sharaf M, Contre C, Theander E, Queiro R, Zimmermann M, Gossec L. PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis. Rheumatol Ther. 2023 Apr;10(2):489-505. doi: 10.1007/s40744-022-00518-w. Epub 2022 Dec 30.

    PubMed 36585602

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Psoriatic, run by Janssen Pharmaceutica N.V., Belgium at 155 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in Germany, Canada, France, United Kingdom, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Start and Stop Date of Guselkumab, as Applicable, For Each Participant (time frame: Up to 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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