Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Part of paid clinical trials in Mountain Brook, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04936308
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Participants will receive guselkumab as SC injection.
  • Placebo — DRUG
    Participants will receive matching placebo as SC injection.

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Key Dates

Start date
Sep 28, 2021
Status verified
Jun 2026
Primary completion
Oct 28, 2024
Completion
Jul 16, 2026

Study Design

Enrollment
453 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Guselkumab and Placebo
    Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
  • Experimental: Group 2: Guselkumab
    Participants will receive guselkumab SC.
  • Experimental: Group 3: Placebo Followed by Guselkumab
    Participants will receive placebo SC and will cross over to receive guselkumab SC.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: At Week 24 ]

Locations (50)

FacilityCityStateZIPSite coordinators
Arthritis AssociatesMountain BrookAlabama35223-
Arizona Arthritis and Rheumatology Research PLLC 2AvondaleArizona85392-
Arizona Arthritis and Rheumatology Research PLLC 3FlagstaffArizona86001-6218-
Arizona Arthritis and Rheumatology Research PLLCMesaArizona85210-
Arizona Arthritis and Rheumatology Research PLLC 1PhoenixArizona85032-
Arizona Arthritis and Rheumatology AssociatesSun CityArizona85351-
Southern Arizona VA Healthcare SystemTucsonArizona85723-
Unity Health-White County Medical CenterSearcyArkansas72143-
Newport Huntington Medical GroupHuntington BeachCalifornia92648-
Medvin Clinical Research 2Thousand OaksCalifornia91360-
Medvin Clinical ResearchTujungaCalifornia91042-
Clinical Research Center of ConnecticutDanburyConnecticut06810-
Bay Pines VA Healthcare SystemBay PinesFlorida33744-
Clinical Research of West FloridaClearwaterFlorida33765-
Omega Research ConsultantsDeBaryFlorida32713-
Advanced Clinical Research of OrlandoOcoeeFlorida34761-
Integral Rheumatology And Immunology SpecialistsPlantationFlorida33324-
Clinical Research of West Florida 1TampaFlorida33606-
Florida Medical Clinic, P.A.ZephyrhillsFlorida33542-
Great Lakes Clinical TrialsChicagoIllinois60640-
Clinic of Robert HozmanSkokieIllinois60076-
The Arthritis and Diabetes ClinicMonroeLouisiana71203-
Johns Hopkins UniversityBaltimoreMaryland21224-
Klein And Associates M D P AHagerstownMaryland21740-
Great Lakes Center of RheumatologyLansingMichigan48911-
Arthritis and Rheumatology Center of MIOkemosMichigan48864-
Clinical Research Institute of Michigan, LLCSaint Clair ShoresMichigan48081-
St. Paul Rheumatology P AEaganMinnesota55121-
Arthritis ConsultantsSt LouisMissouri63141-
Arthritis Rheumatic And Back Disease AssociatesVoorhees TownshipNew Jersey08043-
Albuquerque Center for RheumatologyAlbuquerqueNew Mexico87102-
Arthritis and Osteoperosis Associates of New MexicoLas CrucesNew Mexico88011-
Buffalo Rheumatology and Medicine PLLCOrchard ParkNew York14127-
DJL Clinical Research, PLLCCharlotteNorth Carolina28211-
STAT Research, Inc.VandaliaOhio45377-
Health Research of OklahomaOklahoma CityOklahoma73103-
Rheumatology Associates of OklahomaOklahoma CityOklahoma73116-
Dr. Ramesh GuptaMemphisTennessee38119-
Precision Comprehensive Clinical Research SolutionsColleyvilleTexas76034-
Adriana Pop Moody MD Clinic PACorpus ChristiTexas78404-
Metroplex Clinical Research CenterDallasTexas75231-
Precision Comprehensive Clinical Research Solutions 1Fort WorthTexas76107-
West Texas Clinical ResearchLubbockTexas79424-
Southwest Rheumatology Research LLCMesquiteTexas75150-
Texas Rheumatology CarePlanoTexas75024-
Advanced Rheumatology of HoustonThe WoodlandsTexas77382-
DM Clinical ResearchTomballTexas77375-
Arthritis And Osteoporosis ClinicWacoTexas76710-
Arthritis Northwest PLLC 1SpokaneWashington99204-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-

Related coverage on Hipa.ai

Find similar trials in Mountain Brook, AL

By research site
Arthritis Associates· Mountain Brook, ALArizona Arthritis and Rheumatology Research PLLC 2· Avondale, AZArizona Arthritis and Rheumatology Research PLLC 3· Flagstaff, AZArizona Arthritis and Rheumatology Research PLLC· Mesa, AZArizona Arthritis and Rheumatology Research PLLC 1· Phoenix, AZArizona Arthritis and Rheumatology Associates· Sun City, AZ

Related Studies