Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Guselkumab; Ustekinumab; Placebo
Intervention description: In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24.; In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.; In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Guselkumab; Ustekinumab; Placebo

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab
      in participants with Active Psoriatic Arthritis (PsA).
    

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