About this trial
The purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had inadequate response to standard therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who have definite diagnosis of active psoriatic arthritis (PsA) (according to the ClASsification criteria for Psoriatic Arthritis [CASPAR]) prior to the first administration of study drug and have at least 1 of the PsA subsets: distal interphalangeal joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Participants who are negative for rheumatoid factors
Participants having inadequate response (defined by presence of active arthritis [presence of any swollen or any tender joint]) to standard therapies for 3 months at the highest recommended dose (e.g., conventional disease-modifying antirheumatic drugs [DMARDs] including methotrexate, apremilast, or nonsteroidal anti-inflammatory drugs [NSAIDs]), including biologics naïve patient or have failed, or were intolerant to one or more biological treatments [anti-TNF/IL-17i]
Have no history of TB prior to screening AND
Disqualifiers
History of latent or active granulomatous infection prior to screening
Have a known clinically significant hypersensitivity to guselkumab or to any of the excipients
Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study intervention
Has any known malignancy or has a history of malignancy, or a history of lymphoproliferative disease
Trial design
Single group
Treatments tested in this trial
Guselkumab
DrugGuselkumab will be administered as subcutaneous injection.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Secondary outcomes
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12
ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent (%) improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by VAS scale range: 0 mm= very well to 100 mm= very poor, 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI). The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
Percentage of Participants Who Achieve an ACR 20 Response at Week 24
ACR 20 Response is defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using VAS (0-100 mm, 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by using VAS (scale range: 0 mm= very well to 100 mm= very poor), 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by HAQ-DI. The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) CRP and ESR.
Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24
CRP levels that is the analytic markers of inflammation will be assessed.
Sponsors and contacts
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