Guselkumab: Guselkumab will be administered as subcutaneous injection.
Placebo: Matching placebo will be administered as subcutaneous injection.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24 — Baseline and Week 24 BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
Trial sites (242)
Facility
City
Region
Status
Arizona Arthritis and Rheumatology Research PLLC 1
Avondale
Arizona
Arizona Arthritis & Rheumatology Research, PLLC
Chandler
Arizona
Arizona Arthritis and Rheumatology Research PLLC
Mesa
Arizona
Arizona Arthritis Research, PLC.
Phoenix
Arizona
Arizona Arthritis and Rheumatology Associates
Sun City
Arizona
Southern Arizona VA Healthcare System
Tucson
Arizona
Unity Health-White County Medical Center
Searcy
Arkansas
Kaiser Permanent Medical Center
Fontana
California
Newport Huntington Medical Group
Huntington Beach
California
University Of California San Diego
La Jolla
California
Rheumatology Center of San Diego
San Diego
California
Clinical Research Center of Connecticut
Danbury
Connecticut
Bay Pines VA Healthcare System
Bay Pines
Florida
Integral Rheumatology And Immunology Specialists
Plantation
Florida
Florida Medical Clinic, P.A.
Zephyrhills
Florida
Great Lakes Clinical Trials
Chicago
Illinois
OrthoIllinois
Rockford
Illinois
Willow Rheumatology and Wellness
Willowbrook
Illinois
Johns Hopkins Bayview Medical
Baltimore
Maryland
Klein And Associates M D P A
Hagerstown
Maryland
Clinical Research Institute of Michigan, LLC
Saint Clair Shores
Michigan
St. Paul Rheumatology P A
Eagan
Minnesota
Kansas City Physician Partners
Kansas City
Missouri
Clinvest
Springfield
Missouri
STAT Research, Inc.
Vandalia
Ohio
OHSU Rheumatology Clinic, Marquam Hill
Portland
Oregon
Amarillo Center for Clinical Research
Amarillo
Texas
Austin Regional Clinic
Austin
Texas
Precision Comprehensive Clinical Research Solutions
Colleyville
Texas
Adriana Pop Moody MD Clinic PA
Corpus Christi
Texas
AARA Clinical Research Lone Star Arthritis and Rheumatology 1
Fort Worth
Texas
UT Physicians Center for Autoimmunity
Houston
Texas
AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving
Texas
West Texas Clinical Research
Lubbock
Texas
Southwest Rheumatology Research LLC
Mesquite
Texas
Epic Medical Research
Red Oak
Texas
DM Clinical Research
Tomball
Texas
Swedish Medical Center
Seattle
Washington
Cosultorios Reumatologógicos Pampa
Buenos Aires
Argentina
Consultorios Médicos Dr. Catalán Pellet
Buenos Aires
Argentina
+ 202 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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