A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Phase 3 – large-scale trial before approval
Conditions:
Arthritis, Psoriatic
Sponsor: Janssen Research & Development, LLC
trial.available_in:
БГ
Overview
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.
Who can participate
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
Locations
28
Australia (1)
The Queen Elizabeth Hospital
Adelaide
Bosnia and Herzegovina (1)
University Clinical center Republic of Srpska 1
Banja Luka
Bulgaria (1)
Medical Center Medconsult-Pleven
Pleven
Canada (1)
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's , Newfoundland and Labrador
China (1)
Affiliated Hospital of Hebei University
Baoding
Croatia (1)
Ch Osijek
Osijek
Czech Republic (1)
Revmaclinic
Brno
Estonia (1)
OU Innomedica
Tallinn
Georgia (1)
LTD Unimed Adjara
Batumi
Germany (1)
Rheumatologische Schwerpunktpraxis
Berlin
Greece (1)
Democritus University of Thrace
Alexandroupoli
Hungary (1)
Revita Rendelo
Budapest
Israel (1)
Barzilai Medical Center
Ashkelon
Italy (1)
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania
Latvia (1)
M & M Centrs Ltd
Adazi
Lithuania (1)
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