Guselkumab: Participants will receive guselkumab as SC injection.
Placebo: Participants will receive matching placebo as SC injection.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 — At Week 24 ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.
Trial sites (280)
Facility
City
Region
Status
Rheumatology Associates
Birmingham
Alabama
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff
Arizona
Arizona Arthritis & Rheumatology Associates PC
Glendale
Arizona
Arizona Arthritis & Rheumatology Research, PLLC
Tucson
Arizona
Advanced Medical Research
La Palma
California
Rheumatology Center of San Diego
San Diego
California
Medvin Clinical Research, Inc.
Whittier
California
Heuer M.D. Research
Orlando
Florida
The Arthritis Center, Inc.
Palm Harbor
Florida
Forcare Clinical Research Inc
Tampa
Florida
Klein And Associates M D P A
Hagerstown
Maryland
Advanced Rheumatology
Okemos
Michigan
Arthritis Consultants
St Louis
Missouri
Glacier View Research Institute
Kalispell
Montana
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn
New York
PMG Research of Salisbury
Salisbury
North Carolina
STAT Research, Inc.
Springboro
Ohio
Altoona Center For Clinical Research
Duncansville
Pennsylvania
Dr. Ramesh Gupta
Memphis
Tennessee
Austin Regional Clinic
Austin
Texas
Adriana Pop Moody MD Clinic PA
Corpus Christi
Texas
Southwest Rheumatology Research LLC
Mesquite
Texas
Arthritis And Osteoporosis Clinic
Waco
Texas
The Queen Elizabeth Hospital
Adelaide
Australia
Southern Clinical Research
Hobart
Australia
Emeritus Research
Melbourne
Australia
Eastern Health - Box Hill Hospital
Melbourne
Australia
Rheumatology Research Unit
Sunshine Coast
Australia
University Clinical center Republic of Srpska 1
Banja Luka
Bosnia and Herzegovina
University Clinical center Republic of Srpska
Banja Luka
Bosnia and Herzegovina
Health center Gradiska
Gradiska
Bosnia and Herzegovina
Clinical hospital Mostar
Mostar
Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo
Bosnia and Herzegovina
Medical Center Medconsult-Pleven
Pleven
Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv
Bulgaria
UMHAT Kaspela 1
Plovdiv
Bulgaria
UMHAT Kaspela
Plovdiv
Bulgaria
MHAT Trimantium
Plovdiv
Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv
Bulgaria
Medical Center Unimed Plovdiv
Plovdiv
Bulgaria
+ 240 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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