A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants
ConditionArthritis, Psoriatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will include participants affected with psoriatic arthritis (PsA) according to classification for psoriatic arthritis (CASPAR) criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Group 1: Psoriatic Arthritis Participants Treated With Guselkumab
Trial outcomes
Primary outcomes
1
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 year2
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 weeks3
Number of Participants Starting New Treatment
Participants starting new treatment along with reason of discontinuation will be reported.
Time frame
At 1 yearSecondary outcomes
1
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 years2
Percentage of Participants Discontinuing The Treatment
Participants discontinuing the treatment along with the reasons will be reported.
Time frame
At 2 years3
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 244
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 24Sponsors and contacts
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Source ClinicalTrials.gov