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

Janssen (J&J Innovative Medicine)

Status: Active, not recruiting

Conditions: Arthritis, Psoriatic

Treatments: Drug: Guselkumab; Drug: IL-17i

Study type: Observational

Funder types: Industry

Identifiers

NCT05049798

CR108938

CNTO1959PSA4001 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,314 participants in 2 patient groups

Cohort 1: Guselkumab

Description:

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.

Treatment:

Drug: Guselkumab

Cohort 2: Interleukin-17 inhibitor (IL-17i)

Description:

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:

Drug: IL-17i