A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants (PEGASUS)

A Real-World, Prospective Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Arthritis, Psoriatic

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hopital Roger Salengro - CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria:

• 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
• The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Still Receiving Treatment at 2 years	Percentage of participants still receiving treatment at 2 years will be reported.	At 2 years
Percentage of Participants Discontinuing The Treatment	Participants discontinuing the treatment along with the reasons will be reported.	At 2 years
Change From Baseline in Disease Activity Index in Psoriatic Arthritis (DAPSA)/ Clinical Disease Activity Index in Psoriatic Arthritis (cDAPSA)	The DAPSA was developed to characterize psoriatic arthritis (PsA) disease activity. It considers the number of painful and swollen joints, the patient's assessment of their disease and the C-reactive protein (CRP) measurement for acute inflammation. Where CRP measurements are not available, the clinical DAPSA (cDAPSA) maybe be used, which omits CRP. An overall score is calculated, where higher scores correspond to higher disease activity. Cut-off values for DAPSA low and high disease activity are: ≤14 and >28 points, respectively, and for remission is ≤4 points. The cut-off values for cDAPSA are: ≤4 points for remission, >4 to ≤13 points for low disease activity, > 13 to ≤27 points for moderate disease activity, and >27 points for high disease activity.	Baseline, Months 3,6,12,18, and 24
Change From Baseline in Leeds Enthesitis Index (LEI) Score	The Leeds enthesitis index (LEI) measures the activity of enthesitis in PsA. The index measures the severity and activity of enthesitis, inflammation at the attachment of the ligaments and tendons to bone. The clinical assessor must elicit tenderness at 6 enthesitis sites: both lateral epicondyles of the humerus, both medial condyles of the femur, and the Achilles tendon insertions. Each site affected is summed to give a score out of 6, where 6 indicates all sites affected.	Baseline, Months 3,6,12,18, and 24
Change From Baseline in Back and Neck Pain Numerical Rating Scale (NRS) Score	NRS for back and neck pain will be administered. This is a simple numbered 0-10 scale on which the patient indicates the intensity of their pain (0 represents no pain and 10 indicates the worst possible pain).	Baseline, Months 3,6,12,18, and 24
Hazard Ratios Between Baseline Clinical Factors and Guselkumab Persistence and Effectiveness at Months 12 and 24	Hazard ratios for association between baseline clinical factors and persistence/effectiveness from Cox proportional hazards models will be reported.	At Month 12 and 24
Sociodemographic Characteristics: Age	Participant's age will be reported.	At Baseline
Sociodemographic Characteristics: Sex	Participant's sex (male, female) will be reported	At Baseline
Sociodemographic Characteristics: Weight	Participant's weight will be reported	At Baseline
Sociodemographic Characteristics: Height	Participant's height will be reported.	At Baseline
Sociodemographic Characteristics: Body Mass Index (BMI)	Participant's BMI will be reported.	At Baseline
Number of Participants Reporting Smoking, Cannabis and Alcohol Use	Participant's smoking, use of Cannabis and Alcohol habit will be reported.	At Baseline
Number of Participants With Family History of Psoriasis and/or Psoriatic Arthritis and/or Spondyloarthritis	Family history of psoriasis and/or psoriatic arthritis and/or spondyloarthritis wil be reported.	At Baseline
Date of Diagnosis of Psoriatic Arthritis	Date of diagnosis of psoriatic arthritis will be reported.	At Baseline
Date of Previous Treatments of Psoriatic Arthritis	Date of previous treatments of psoriatic arthritis will be reported.	At Baseline
Duration of Previous Treatments of Psoriatic Arthritis	Duration of previous treatments of psoriatic arthritis will be reported.	At Baseline
Medical History and Current Situation	Participants medical history and current medical situation will be reported.	At Baseline
Number of Participants Receiving Co-occurring Treatments Linked to Psoriatic Arthritis	Participants receiving co-occurring treatments linked to psoriatic arthritis at baseline and during follow-up will be reported.	Baseline up to 2 Years
Failure to Achieve or Maintain Response	Failure to achieve or maintain response to at least 2 biologic/targeted synthetic DMARDs with at least 2 different mechanisms of action (Y/N) (For treatment refractory criteria).	Up to 2 Years
Number of Participants Reporting Problems Related to the Management of Signs and Symptoms	The management of signs and/or symptoms that is perceived as problematic by the rheumatologist and/or the participants will be reported.	At baseline
Evidence of Persistent Disease	Evidence of persistent disease as defined by at least 2 of the following: a) failure to achieve or maintain low disease activity, b) the presence of active extra-musculoskeletal manifestations of PsA, c) objective evidence of inflammatory activity, namely clinical signs, elevated acute phase reactants and/or imaging findings suggestive of inflammation.	Up to 2 Years
Number of Participants with Co-Morbidities	Number of participants with co-morbidities will be reported.	At baseline
Number of Participants with Abnormal Psychosocial Factors	Number of participants with abnormal psychosocial factors will be reported.	At Baseline
Healthcare Professional (HCP): Age Group	Age group of HCP will be reported.	At Baseline
HCP: Sex	Sex of HCP will be reported.	At Baseline
HCP: Experience	Experience of HCP will be reported.	At Baseline
HCP: Type of Practice	Type of practice of HCP will be reported.	At Baseline
Number of Participants With Adverse Events, Serious Adverse Events, Infections and Injection Site Reactions	AEs with onset or worsening on or after date of first dose of study treatment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1 equal (=) Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. SAE is any untoward medical occurrence that results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	Up to 2 Years
Tolerance Related Guselkumab Treatment	Tolerance Related guselkumab treatment will be reported.	Up to 2 Years
Dose at Initiation of Guselkumab	Dose at initiation of guselkumab will be reported.	At Months 0, 3, 6, 12, 18 and 24
Treatment Interval at Initiation of Guselkumab	Treatment interval at initiation of guselkumab will be reported.	At Months 0, 3, 6, 12, 18 and 24
Type of Injection	Type of injection will be reported.	At Months 0, 3, 6, 12, 18 and 24
Number of Participants Reporting Change of Injection Frequency	Participants reporting change of injection frequency (Q4 to Q8 or Q8 to Q4) and its reason will be reported.	At Months 0, 3, 6, 12, 18 and 24
Number of Participant With Co-occurring Treatments Linked to PSA	Participants with co-occurring treatments linked to PSA will be reported.	At Months 0, 3, 6, 12, 18 and 24
Number of Participants With Reason for Choosing Guselkumab From the Therapeutic Arsenal	Participants with reason for choosing guselkumab from the therapeutic arsenal will be reported.	At Months 0, 3, 6, 12, 18 and 24
Number of Participants Switching to New Treatment in Case of Discontinuation of Guselkumab Treatment	Participants switching to new treatment in case of discontinuation of guselkumab treatment will be reported.	At Months 0, 3, 6, 12, 18 and 24
Change From Baseline in 12-item Psoriatic Arthritis Impact of Disease Questionnaire (PsAID-12) Questionnaire Score	The PsAID-12 questionnaire was designed to assess the impact of disease, with questions on pain, physical function, fatigue, coping and depression. It is a validated, self-administered questionnaire developed for use in clinical practice that assesses the impact of PsA on patients' 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, Months 0, 3, 6, 12, 18 and 24
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Each Visit After Baseline	The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) was developed to measure disease activity in patients with ankylosing spondylitis. It consists of 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 and morning stiffness severity. Each symptom is assessed on a scale of 0-10 where 0 indicates no pain or discomfort and 10 indicates maximum pain or discomfort. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease.	Baseline, Months 0, 3, 6, 12, 18 and 24
Satisfaction of Treatment for the Participants	The satisfaction of treatment for the participant will be assessed using a 5-point Likert scale, ("Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied"). The scale includes two patient reported questions: "1) How satisfied or dissatisfied are you with the overall convenience of this medication" and "2) How satisfied or dissatisfied are you with the ability of this medication ability to treat your condition?" Scores range from Very dissatisfied to Very satisfied and will be used to evaluate satisfaction with guselkumab treatment.	At Months 3, 6, 12, 18 and 24
Satisfaction of Treatment Care Management and Patient Relationship for the Rheumatologist	Satisfaction of treatment care management and patient relationship for the rheumatologist will be assessed using a 5-point Likert scale specified as : "Very dissatisfied, Dissatisfied, Neither satisfied nor dissatisfied, Satisfied and Very satisfied." The physician-reported questions are: "1) How satisfied or dissatisfied are you with this drug overall for this patient?" and "2) How satisfied or dissatisfied are you with the ease of managing your patient with guselkumab?"	At Months 3, 6, 12, 18 and 24

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.
• Investigators: Study Director: Janssen-Cilag France Clinical Trial, Janssen-Cilag France

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2026
• Primary Completion (Estimated): December 10, 2029
• Study Completion (Estimated): December 10, 2029

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic
• Other Study ID Numbers: CNTO1959PSA4021 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No