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

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT04929210

Run by

Janssen Research & Development, LLC

People needed

411

Starts

2021-08-30

Expected to finish

2027-04-13

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis & Rheumatology Research, PLLC — Chandler, Arizona, United States
• Arizona Arthritis and Rheumatology Research PLLC — Mesa, Arizona, United States
• Arizona Arthritis Research, PLC. — Phoenix, Arizona, United States
• Arizona Arthritis and Rheumatology Associates — Sun City, Arizona, United States
• Southern Arizona VA Healthcare System — Tucson, Arizona, United States
• Unity Health-White County Medical Center — Searcy, Arkansas, United States
• Kaiser Permanent Medical Center — Fontana, California, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• University Of California San Diego — La Jolla, California, United States
• Rheumatology Center of San Diego — San Diego, California, United States
• Clinical Research Center of Connecticut — Danbury, Connecticut, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
• Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• OrthoIllinois — Rockford, Illinois, United States
• Willow Rheumatology and Wellness — Willowbrook, Illinois, United States
• Johns Hopkins Bayview Medical — Baltimore, Maryland, United States
• Klein And Associates M D P A — Hagerstown, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Saint Clair Shores, Michigan, United States
• St. Paul Rheumatology P A — Eagan, Minnesota, United States
• Kansas City Physician Partners — Kansas City, Missouri, United States
• Clinvest — Springfield, Missouri, United States
• STAT Research, Inc. — Vandalia, Ohio, United States
• Arizona Arthritis and Rheumatology Research PLLC 1 — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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