A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: All

Summary

The primary 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Have a diagnosis of Psoriatic Arthritis (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 at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciLitre (mg/dL) at screening from the central laboratory

• Have 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

• Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis

• Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance

• Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation

Exclusion Criteria:

• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease

• Has ever received more than 2 anti-TNFalpha agents

• Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment

• Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent

• Has received apremilast within 4 weeks prior to the first administration of study agent

• Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor