RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Quick Facts

Study Start:2021-08-30
Study Completion:2026-11-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04929210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * 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)
  4. * 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
  5. * 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
  1. * Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
  2. * 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
  3. * Has previously received any biologic treatment
  4. * 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
  5. * 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

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Arizona Arthritis & Rheumatology Research, PLLC
Chandler, Arizona, 85225
United States
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, 85210
United States
Arizona Arthritis Research, PLC.
Phoenix, Arizona, 85032
United States
Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona, 85037
United States
Arizona Arthritis and Rheumatology Associates
Sun City, Arizona, 85351
United States
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723
United States
Unity Health-White County Medical Center
Searcy, Arkansas, 72143
United States
Newport Huntington Medical Group
Huntington Beach, California, 92648
United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810
United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324
United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542
United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
OrthoIllinois
Rockford, Illinois, 61114
United States
Willow Rheumatology and Wellness
Willowbrook, Illinois, 60527
United States
Johns Hopkins Bayview Medical
Baltimore, Maryland, 21224
United States
Klein And Associates M D P A
Hagerstown, Maryland, 21740
United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081
United States
St. Paul Rheumatology P A
Eagan, Minnesota, 55121
United States
Clinvest
Springfield, Missouri, 65807
United States
STAT Research, Inc.
Vandalia, Ohio, 45377
United States
OHSU Rheumatology Clinic, Marquam Hill
Portland, Oregon, 97239
United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
United States
Austin Regional Clinic
Austin, Texas, 78731
United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
United States
Adriana Pop Moody MD Clinic PA
Corpus Christi, Texas, 78404
United States
UT Physicians Center for Autoimmunity
Houston, Texas, 77030
United States
West Texas Clinical Research
Lubbock, Texas, 79424
United States
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150
United States
Epic Medical Research
Red Oak, Texas, 75154
United States
DM Clinical Research
Tomball, Texas, 77375
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-30
Study Completion Date2026-11-10

Study Record Updates

Study Start Date2021-08-30
Study Completion Date2026-11-10

Terms related to this study

Additional Relevant MeSH Terms

  • Arthritis, Psoriatic