Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02319759
Eligibility Criteria:
Inclusion Criteria:
* Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
* Had active PsA as defined by:
1. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
2. C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
* Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (\>=) 3% at Screening and baseline
* Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable
Exclusion Criteria:
* Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
* Has previously received guselkumab or ustekinumab
* Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
* Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
* Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02319759
Study Brief:
Protocol Section:
NCT02319759