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.
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
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
Johnson & Johnson Private Limited
Lead sponsor