A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants

NCT07532226 | Not Yet Recruiting

• 1 other identifier: CNTO1959PSA4021
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants Still Receiving Treatment at 1 Year

  Discontinuation or maintenance of guselkumab treatment will be recorded by the physician at each visit. Proportion of participants still receiving treatment will be reported in the outcome measure.

  At 1 year

• Percentage of Participants Still Receiving Treatment at Persistence Time

  Persistence time of the initial treatment: defined as the time from the date of the first administration of guselkumab to the date that the last dose of guselkumab treatment was administered plus 1 dosing interval (8 weeks), or until start of subsequent treatment.

  Up to 8 weeks

• Number of Participants Starting New Treatment

  Participants starting new treatment along with reason of discontinuation will be reported.

  At 1 year

Secondary Outcomes (40)

• Percentage of Participants Still Receiving Treatment at 2 years

  At 2 years

• Percentage of Participants Discontinuing The Treatment

  At 2 years

• Change From Baseline in Disease Activity Index in Psoriatic Arthritis (DAPSA)/ Clinical Disease Activity Index in Psoriatic Arthritis (cDAPSA)

  Baseline, Months 3,6,12,18, and 24

• Change From Baseline in Leeds Enthesitis Index (LEI) Score

  Baseline, Months 3,6,12,18, and 24

• Change From Baseline in Back and Neck Pain Numerical Rating Scale (NRS) Score

  Baseline, Months 3,6,12,18, and 24

Study Arms (1)

Group 1: Psoriatic Arthritis Participants Treated With Guselkumab

Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per routine clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants affected with psoriatic arthritis (PsA) according to classification for psoriatic arthritis (CASPAR) criteria.

You may qualify if:

• Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR)
• Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study
• Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication
• Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements

You may not qualify if:

• Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment.
• Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase \[JAK\] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time
• Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis)
• 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-Cilag France-sponsored observational clinical study
• Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen-Cilag France Clinical Trial

  Janssen-Cilag France

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 3, 2029
• Study Completion (Estimated): December 13, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share