A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis (APEX)

  • STATUS
    Recruiting
  • End date
    Sep 23, 2026
  • participants needed
    950
  • sponsor
    Janssen Research & Development, LLC
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Updated on 25 October 2022
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psoriasis
NSAID
DMARD
anti-rheumatic drugs
spondylitis
apremilast
rheumatoid nodules
psoriatic plaque
arthritis mutilans
peripheral arthritis
polyarticular arthritis
biological drug

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Details
Condition Arthritis, Psoriatic
Treatment Placebo, Guselkumab
Clinical Study IdentifierNCT04882098
SponsorJanssen Research & Development, LLC
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis

Exclusion Criteria

Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
Has previously received any biologic treatment
Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
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psoriasis
NSAID
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spondylitis
apremilast
rheumatoid nodules
psoriatic plaque
arthritis mutilans
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polyarticular arthritis
biological drug

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