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A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

NCT04929210

Active Not RecruitingPhase 4

Sponsor: Janssen Research & Development, LLC

Conditions: Arthritis, Psoriatic

Interventions: Guselkumab, Placebo

Countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, Denmark, Georgia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale \[VAS\]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of \>= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Exclusion Criteria:

* Has known allergies, hypersensitivity, or intolerance to guselkumab 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), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational 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 (240)

Avondale, Arizona, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Searcy, Arkansas, United States
Fontana, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
San Diego, California, United States
Danbury, Connecticut, United States
Bay Pines, Florida, United States
Plantation, Florida, United States
Zephyrhills, Florida, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
Willowbrook, Illinois, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Saint Clair Shores, Michigan, United States
Eagan, Minnesota, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
Vandalia, Ohio, United States
Portland, Oregon, United States
Amarillo, Texas, United States
Austin, Texas, United States
Colleyville, Texas, United States
Corpus Christi, Texas, United States
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