A Study of Golimumab in Participants With Active Psoriatic Arthritis

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02181673
Phase
PHASE3
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.
  • Golimumab — DRUG
    Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.

Study Details

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).

Key Dates

Start date
Sep 8, 2014
Status verified
Dec 2017
Primary completion
May 5, 2016
Completion
Mar 22, 2017

Study Design

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

Arms

  • Placebo Comparator: Treatment Group 1: Placebo
    Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52.
  • Experimental: Treatment Group 2: Golimumab
    Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Week 14 ]

Locations (13)

FacilityCityStateZIPSite coordinators
-GlendaleArizona--
-MesaArizona--
-Huntington BeachCalifornia--
-LakewoodCalifornia--
-GrangerIndiana--
-IndianapolisIndiana--
-MonroeLouisiana--
-TupeloMississippi--
-St LouisMissouri--
-Orchard ParkNew York--
-SalisburyNorth Carolina--
-DuncansvillePennsylvania--
-AustinTexas--

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