A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04882098
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) by assessing the reduction in signs and symptoms of PsA.

Key Dates

Start date
Jun 17, 2021
Status verified
Jun 2026
Primary completion
Dec 30, 2024
Completion
Oct 5, 2027

Study Design

Enrollment
1,054 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. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
  • Experimental: Group 2: Guselkumab
    Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
  • Experimental: Group 3: Placebo Followed by Guselkumab
    Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will 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 (23)

FacilityCityStateZIPSite coordinators
Rheumatology AssociatesBirminghamAlabama35205-
Arizona Arthritis and Rheumatology Research PLLCFlagstaffArizona86001-6218-
Arizona Arthritis & Rheumatology Associates PCGlendaleArizona85306-
Arizona Arthritis & Rheumatology Research, PLLCTucsonArizona85704-
Advanced Medical ResearchLa PalmaCalifornia90624-
Rheumatology Center of San DiegoSan DiegoCalifornia92128-
Medvin Clinical Research, Inc.WhittierCalifornia90606-
Heuer M.D. ResearchOrlandoFlorida32819-
The Arthritis Center, Inc.Palm HarborFlorida34684-
Forcare Clinical Research IncTampaFlorida33624-
Klein And Associates M D P AHagerstownMaryland21740-
Advanced RheumatologyOkemosMichigan48864-
Arthritis ConsultantsSt LouisMissouri63141-
Glacier View Research InstituteKalispellMontana59901-3158-
NYU Langone Ambulatory Care Brooklyn HeightsBrooklynNew York11201-
PMG Research of SalisburySalisburyNorth Carolina28144-
STAT Research, Inc.SpringboroOhio45342-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Dr. Ramesh GuptaMemphisTennessee38119-
Austin Regional ClinicAustinTexas78731-
Adriana Pop Moody MD Clinic PACorpus ChristiTexas78404-
Southwest Rheumatology Research LLCMesquiteTexas75150-
Arthritis And Osteoporosis ClinicWacoTexas76710-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
Rheumatology Associates· Birmingham, ALArizona Arthritis and Rheumatology Research PLLC· Flagstaff, AZArizona Arthritis & Rheumatology Associates PC· Glendale, AZArizona Arthritis & Rheumatology Research, PLLC· Tucson, AZAdvanced Medical Research· La Palma, CARheumatology Center of San Diego· San Diego, CA

Related Studies