Arthritis, PsoriaticPEGASUSNCT07532226
A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants
An observational study of Arthritis, Psoriatic, run by Janssen-Cilag Ltd. at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2026to 10 Dec 2029
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants affected with psoriatic arthritis (PsA) according to classification for psoriatic arthritis (CASPAR) criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Roger Salengro - CHU Lille
Lille, 59037
About this study
Official title: 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).
- Conditions
- Arthritis, Psoriatic
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 8 weeks
Number of Participants Starting New Treatment
Participants starting new treatment along with reason of discontinuation will be reported.
Measured: At 1 year
Secondary outcomes (40)
Percentage of Participants Still Receiving Treatment at 2 years
Percentage of participants still receiving treatment at 2 years will be reported.
Measured: At 2 years
Percentage of Participants Discontinuing The Treatment
Participants discontinuing the treatment along with the reasons will be reported.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At Month 12 and 24
Sociodemographic Characteristics: Age
Participant's age will be reported.
Measured: At Baseline
Sociodemographic Characteristics: Sex
Participant's sex (male, female) will be reported
Measured: At Baseline
Sociodemographic Characteristics: Weight
Participant's weight will be reported
Measured: At Baseline
Sociodemographic Characteristics: Height
Participant's height will be reported.
Measured: At Baseline
Sociodemographic Characteristics: Body Mass Index (BMI)
Participant's BMI will be reported.
Measured: At Baseline
Number of Participants Reporting Smoking, Cannabis and Alcohol Use
Participant's smoking, use of Cannabis and Alcohol habit will be reported.
Measured: 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.
Measured: At Baseline
Date of Diagnosis of Psoriatic Arthritis
Date of diagnosis of psoriatic arthritis will be reported.
Measured: At Baseline
Date of Previous Treatments of Psoriatic Arthritis
Date of previous treatments of psoriatic arthritis will be reported.
Measured: At Baseline
Duration of Previous Treatments of Psoriatic Arthritis
Duration of previous treatments of psoriatic arthritis will be reported.
Measured: At Baseline
Medical History and Current Situation
Participants medical history and current medical situation will be reported.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 2 Years
Number of Participants with Co-Morbidities
Number of participants with co-morbidities will be reported.
Measured: At baseline
Number of Participants with Abnormal Psychosocial Factors
Number of participants with abnormal psychosocial factors will be reported.
Measured: At Baseline
Healthcare Professional (HCP): Age Group
Age group of HCP will be reported.
Measured: At Baseline
HCP: Sex
Sex of HCP will be reported.
Measured: At Baseline
HCP: Experience
Experience of HCP will be reported.
Measured: At Baseline
HCP: Type of Practice
Type of practice of HCP will be reported.
Measured: 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.
Measured: Up to 2 Years
Tolerance Related Guselkumab Treatment
Tolerance Related guselkumab treatment will be reported.
Measured: Up to 2 Years
Dose at Initiation of Guselkumab
Dose at initiation of guselkumab will be reported.
Measured: At Months 0, 3, 6, 12, 18 and 24
Treatment Interval at Initiation of Guselkumab
Treatment interval at initiation of guselkumab will be reported.
Measured: At Months 0, 3, 6, 12, 18 and 24
Type of Injection
Type of injection will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: At Months 3, 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 Apr 2026
- Primary completion10 Dec 2029 (estimated)
- Study completion10 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag France Clinical Trial, Study director, Janssen-Cilag France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532226
- Sponsor's protocol ID
- CNTO1959PSA4021
- Other IDs
- CNTO1959PSA4021
- Acronym
- PEGASUS
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.