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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05049798




Registration number
NCT05049798
Ethics application status
Date submitted
31/08/2021
Date registered
20/09/2021

Titles & IDs
Public title
A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice
Scientific title
Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
Secondary ID [1] 0 0
CNTO1959PSA4001
Secondary ID [2] 0 0
CR108938
Universal Trial Number (UTN)
Trial acronym
PsABIOnd
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - IL-17i

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Start and Stop Date of Guselkumab, as Applicable, For Each Participant
Timepoint [1] 0 0
Up to 39 months
Primary outcome [2] 0 0
The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant
Timepoint [2] 0 0
Up to 39 months
Secondary outcome [1] 0 0
Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively
Timepoint [1] 0 0
Baseline up to 39 months
Secondary outcome [2] 0 0
Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)
Timepoint [2] 0 0
Baseline up to 39 months
Secondary outcome [3] 0 0
Change from Baseline in Assessment of Dactylitis
Timepoint [3] 0 0
Baseline up to 39 months
Secondary outcome [4] 0 0
Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)
Timepoint [4] 0 0
Baseline up to 39 months
Secondary outcome [5] 0 0
Change from Baseline in Nail Involvement
Timepoint [5] 0 0
Baseline up to 39 months
Secondary outcome [6] 0 0
Change from Baseline in Body Surface Area (BSA) Psoriasis (PSO) Skin Involvement
Timepoint [6] 0 0
Baseline up to 39 months
Secondary outcome [7] 0 0
Change from Baseline in C-reactive Protein (CRP)
Timepoint [7] 0 0
Baseline up to 39 months
Secondary outcome [8] 0 0
Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)
Timepoint [8] 0 0
Baseline up to 39 months
Secondary outcome [9] 0 0
Change from Baseline in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA/DAPSA)
Timepoint [9] 0 0
Baseline up to 39 months
Secondary outcome [10] 0 0
Response as a Measure of Clinical Improvement in cDAPSA/DAPSA
Timepoint [10] 0 0
Up to 39 months
Secondary outcome [11] 0 0
Start and Stop Dates of All Treatments and the Sequence of Treatment Lines
Timepoint [11] 0 0
Up to 39 months
Secondary outcome [12] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [12] 0 0
Up to 39 months
Secondary outcome [13] 0 0
BSA PSO Skin Involvement
Timepoint [13] 0 0
Up to 39 months
Secondary outcome [14] 0 0
Rheumatic Disease Comorbidity Index
Timepoint [14] 0 0
Up to 39 months
Secondary outcome [15] 0 0
Change from Baseline in Fibromyalgia Rapid Screening Tool (FiRST)
Timepoint [15] 0 0
Baseline up to 6 months
Secondary outcome [16] 0 0
Change from Baseline in European Quality of Life (EuroQoL) 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L)
Timepoint [16] 0 0
Baseline up to 39 months
Secondary outcome [17] 0 0
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [17] 0 0
Baseline up to 39 months
Secondary outcome [18] 0 0
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12)
Timepoint [18] 0 0
Baseline up to 39 months
Secondary outcome [19] 0 0
Change from Baseline in Patient Global Disease Activity Visual Analog Scale (VAS) Scores
Timepoint [19] 0 0
Baseline up to 39 months
Secondary outcome [20] 0 0
Change from Baseline in Pain VAS Score
Timepoint [20] 0 0
Baseline up to 39 months
Secondary outcome [21] 0 0
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timepoint [21] 0 0
Baseline up to 39 months
Secondary outcome [22] 0 0
Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP)
Timepoint [22] 0 0
Baseline up to 39 months
Secondary outcome [23] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI)
Timepoint [23] 0 0
Baseline up to 39 months
Secondary outcome [24] 0 0
Change from Baseline in Patient Acceptable Symptom State (PASS)
Timepoint [24] 0 0
Baseline up to 39 months
Secondary outcome [25] 0 0
Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI: PsA)
Timepoint [25] 0 0
Baseline up to 39 months
Secondary outcome [26] 0 0
Change from Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
Timepoint [26] 0 0
Baseline up to 39 months
Secondary outcome [27] 0 0
Number of Participants Switching or Stopping Treatment
Timepoint [27] 0 0
Up to 39 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
Accrual to date
Final
1314
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Footscray Hospital, Western Health - Footscray
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
- Footscray
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autónoma de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba
Country [4] 0 0
Argentina
State/province [4] 0 0
San Fernando Buenos Aires
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Belgium
State/province [9] 0 0
Brugge
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussel
Country [11] 0 0
Belgium
State/province [11] 0 0
Genk
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
Colombia
State/province [20] 0 0
Bogota
Country [21] 0 0
Colombia
State/province [21] 0 0
Bucaramanga
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellin
Country [23] 0 0
Colombia
State/province [23] 0 0
Medellín
Country [24] 0 0
Colombia
State/province [24] 0 0
Montería
Country [25] 0 0
France
State/province [25] 0 0
Bobigny
Country [26] 0 0
France
State/province [26] 0 0
Cholet
Country [27] 0 0
France
State/province [27] 0 0
Clermont Ferrand
Country [28] 0 0
France
State/province [28] 0 0
Creteil
Country [29] 0 0
France
State/province [29] 0 0
Echirolles
Country [30] 0 0
France
State/province [30] 0 0
Lille
Country [31] 0 0
France
State/province [31] 0 0
Lyon
Country [32] 0 0
France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Orléans
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Strasbourg Cedex
Country [36] 0 0
France
State/province [36] 0 0
Toulouse
Country [37] 0 0
Germany
State/province [37] 0 0
Amberg
Country [38] 0 0
Germany
State/province [38] 0 0
Bayreuth
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Dusseldorf
Country [41] 0 0
Germany
State/province [41] 0 0
Erfurt
Country [42] 0 0
Germany
State/province [42] 0 0
Frankfurt
Country [43] 0 0
Germany
State/province [43] 0 0
Halle-Saale
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Herne
Country [46] 0 0
Germany
State/province [46] 0 0
Koln
Country [47] 0 0
Germany
State/province [47] 0 0
Leipzig
Country [48] 0 0
Germany
State/province [48] 0 0
Magdeburg
Country [49] 0 0
Germany
State/province [49] 0 0
München
Country [50] 0 0
Germany
State/province [50] 0 0
Neubrandenburg
Country [51] 0 0
Germany
State/province [51] 0 0
Püttlingen
Country [52] 0 0
Germany
State/province [52] 0 0
Ratingen
Country [53] 0 0
Germany
State/province [53] 0 0
Templin
Country [54] 0 0
Germany
State/province [54] 0 0
Vogelsang-Gommern
Country [55] 0 0
Greece
State/province [55] 0 0
Athens
Country [56] 0 0
Greece
State/province [56] 0 0
Ioannina
Country [57] 0 0
Greece
State/province [57] 0 0
Patras
Country [58] 0 0
Greece
State/province [58] 0 0
Patra
Country [59] 0 0
Greece
State/province [59] 0 0
Thessaloniki
Country [60] 0 0
Italy
State/province [60] 0 0
Bari
Country [61] 0 0
Italy
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Campobasso
Country [62] 0 0
Italy
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Catanzaro
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Italy
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Firenze
Country [64] 0 0
Italy
State/province [64] 0 0
Napoli
Country [65] 0 0
Italy
State/province [65] 0 0
Palermo
Country [66] 0 0
Italy
State/province [66] 0 0
Pisa
Country [67] 0 0
Italy
State/province [67] 0 0
Potenza
Country [68] 0 0
Italy
State/province [68] 0 0
Rome
Country [69] 0 0
Italy
State/province [69] 0 0
Rozzano
Country [70] 0 0
Italy
State/province [70] 0 0
Torino
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Italy
State/province [71] 0 0
Udine
Country [72] 0 0
Italy
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Verona
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Japan
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Hyogo
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Japan
State/province [74] 0 0
Meguro-ku
Country [75] 0 0
Japan
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Osaka
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Japan
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Sapporo
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Japan
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Tokyo
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Korea, Republic of
State/province [78] 0 0
Cheonan-si
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Seongnam
Country [80] 0 0
Korea, Republic of
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Seoul
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Mexico
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Merida
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Mexico
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Mexico
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Mexico
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Zapopan
Country [84] 0 0
Netherlands
State/province [84] 0 0
Amsterdam
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Netherlands
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Enschede
Country [86] 0 0
Netherlands
State/province [86] 0 0
Groningen
Country [87] 0 0
Netherlands
State/province [87] 0 0
Helmond
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Kemerovo
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Moscow
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Russian Federation
State/province [90] 0 0
Tomsk
Country [91] 0 0
Spain
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A Coruna
Country [92] 0 0
Spain
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Algeciras / Cadiz
Country [93] 0 0
Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Cordoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Santiago de Compostela
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Spain
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Sevilla
Country [101] 0 0
Sweden
State/province [101] 0 0
Göteborg
Country [102] 0 0
Sweden
State/province [102] 0 0
Lund
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Sweden
State/province [103] 0 0
Orebro
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Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Sweden
State/province [105] 0 0
Uppsala
Country [106] 0 0
Switzerland
State/province [106] 0 0
Fribourg
Country [107] 0 0
Taiwan
State/province [107] 0 0
Kaohsiung
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taichung
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Aberdeen
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Abergavenny
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Airdrie
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Barnet
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Bath
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Glasgow
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Hull
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Leeds
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Manchester
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Newcastle Upon Tyne
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Portsmouth
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Salford
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Southampton
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Staffordshire
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Stamford
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Wishaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Pharmaceutica N.V., Belgium
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Address 0 0
Janssen Pharmaceutica N.V., Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05049798