An observational study in Arthritis, Psoriatic, sponsored by Janssen-Cilag Ltd.. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen-Cilag Ltd. (part of Johnson & Johnson) · Observational
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).
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include participants affected with psoriatic arthritis (PsA) according to classification for psoriatic arthritis (CASPAR) criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Up to 8 weeks
Number of Participants Starting New Treatment
Participants starting new treatment along with reason of discontinuation will be reported.
Time frame: At 1 year
Percentage of Participants Still Receiving Treatment at 2 years
Percentage of participants still receiving treatment at 2 years will be reported.
Time frame: At 2 years
Percentage of Participants Discontinuing The Treatment
Participants discontinuing the treatment along with the reasons will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At Month 12 and 24
Sociodemographic Characteristics: Age
Participant's age will be reported.
Time frame: At Baseline
Sociodemographic Characteristics: Sex
Participant's sex (male, female) will be reported
Time frame: At Baseline
Sociodemographic Characteristics: Weight
Participant's weight will be reported
Time frame: At Baseline
Sociodemographic Characteristics: Height
Participant's height will be reported.
Time frame: At Baseline
Sociodemographic Characteristics: Body Mass Index (BMI)
Participant's BMI will be reported.
Time frame: At Baseline
Number of Participants Reporting Smoking, Cannabis and Alcohol Use
Participant's smoking, use of Cannabis and Alcohol habit will be reported.
Time frame: 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.
Time frame: At Baseline
Date of Diagnosis of Psoriatic Arthritis
Date of diagnosis of psoriatic arthritis will be reported.
Time frame: At Baseline
Date of Previous Treatments of Psoriatic Arthritis
Date of previous treatments of psoriatic arthritis will be reported.
Time frame: At Baseline
Duration of Previous Treatments of Psoriatic Arthritis
Duration of previous treatments of psoriatic arthritis will be reported.
Time frame: At Baseline
Medical History and Current Situation
Participants medical history and current medical situation will be reported.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 Years
Number of Participants with Co-Morbidities
Number of participants with co-morbidities will be reported.
Time frame: At baseline
Number of Participants with Abnormal Psychosocial Factors
Number of participants with abnormal psychosocial factors will be reported.
Time frame: At Baseline
Healthcare Professional (HCP): Age Group
Age group of HCP will be reported.
Time frame: At Baseline
HCP: Sex
Sex of HCP will be reported.
Time frame: At Baseline
HCP: Experience
Experience of HCP will be reported.
Time frame: At Baseline
HCP: Type of Practice
Type of practice of HCP will be reported.
Time frame: 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.
Time frame: Up to 2 Years
Tolerance Related Guselkumab Treatment
Tolerance Related guselkumab treatment will be reported.
Time frame: Up to 2 Years
Dose at Initiation of Guselkumab
Dose at initiation of guselkumab will be reported.
Time frame: At Months 0, 3, 6, 12, 18 and 24
Treatment Interval at Initiation of Guselkumab
Treatment interval at initiation of guselkumab will be reported.
Time frame: At Months 0, 3, 6, 12, 18 and 24
Type of Injection
Type of injection will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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?"
Time frame: At Months 3, 6, 12, 18 and 24
Plan to share: 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.
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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