A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05071664
Phase
PHASE2
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as a SC injection.
  • Golimumab — DRUG
    Golimumab will be administered as a SC injection.
  • Placebo — DRUG
    Placebo will be administered as a SC injection.

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

Key Dates

Start date
Oct 25, 2021
Status verified
Apr 2026
Primary completion
May 14, 2024
Completion
Aug 6, 2024

Study Design

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

Arms

  • Experimental: Group 1: Guselkumab and Golimumab
    Participants will receive subcutaneous (SC) guselkumab and golimumab.
  • Active Comparator: Group 2: Guselkumab and Placebo
    Participants will receive SC guselkumab and placebo.

Primary Outcome Measure

Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24 [ Time Frame: Week 24 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology Research PLLCPhoenixArizona85032-
Arizona Arthritis and Rheumatology Research PLLC 1PhoenixArizona85037-
Unity Health-White County Medical CenterSearcyArkansas72143-
HARAC Research CorpAvon ParkFlorida33825-
Bay Pines VA Healthcare SystemBay PinesFlorida33744-
Omega Research ConsultantsDeBaryFlorida32713-
South Coast Research CenterMiamiFlorida33136-
Advanced Clinical Research of OrlandoOcoeeFlorida34761-
Millennium ResearchOrmond BeachFlorida32174-
Atlanta Research Center for RheumatologyMariettaGeorgia30060-
Great Lakes Center of RheumatologyLansingMichigan48911-
ClinvestSpringfieldMissouri65807-
NYU Langone Ambulatory Care Brooklyn HeightsBrooklynNew York11201-
NYU School of MedicineNew YorkNew York10016-
University of RochesterRochesterNew York14642-
Jacobi Medical CenterThe BronxNew York10461-
STAT Research, Inc.VandaliaOhio45377-
Trinity Universal Research Associates, LLCPlanoTexas75024-
DM Clinical ResearchTomballTexas77375-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Phoenix, AZ

By research site
Arizona Arthritis and Rheumatology Research PLLC· Phoenix, AZArizona Arthritis and Rheumatology Research PLLC 1· Phoenix, AZUnity Health-White County Medical Center· Searcy, ARHARAC Research Corp· Avon Park, FLBay Pines VA Healthcare System· Bay Pines, FLOmega Research Consultants· DeBary, FL

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