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Clinical Trials in the UK / NCT04929210
Active, not recruiting Phase 4

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

NCT04929210 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 4
Started
2021-08-30
Last updated
2026-08-28

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

GuselkumabPlacebo

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)

Trial sites (242)

FacilityCityRegionStatus
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.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT04929210 on ClinicalTrials.gov ↗ ← All trials in the UK