An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Part of paid clinical trials in Orange, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT00488774
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

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

Interventions

  • Placebo — OTHER
    Matching placebo for golimumab, intravenous infusion administered at Week 0
  • Golimumab 1 mg per kg — DRUG
    Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
  • Golimumab 2 mg per kg — DRUG
    Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
  • Golimumab 4 mg per kg — DRUG
    Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Study Details

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

Key Dates

Start date
Aug 31, 2007
Status verified
Apr 2013
Primary completion
May 31, 2009
Completion
May 31, 2009

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0
  • Experimental: Golimumab 1 milligram (mg) per kilogram (kg)
    Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.
  • Experimental: Golimumab 2 mg per kg
    Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.
  • Experimental: Golimumab 4 mg per kg
    Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.

Primary Outcome Measure

Number of Participants With Clinical Response [ Time Frame: Week 6 ]

Locations (36)

FacilityCityStateZIPSite coordinators
-OrangeCalifornia--
-RosevilleCalifornia--
-LittletonColorado--
-BristolConnecticut--
-TampaFlorida--
-Fort DodgeIowa--
-TopekaKansas--
-LouisvilleKentucky--
-LaurelMaryland--
-DearbornMichigan--
-TroyMichigan--
-MexicoMissouri--
-St LouisMissouri--
-LebanonNew Hampshire--
-Great NeckNew York--
-HuntingtonNew York--
-New YorkNew York--
-CharlotteNorth Carolina--
-KinstonNorth Carolina--
-CincinnatiOhio--
-ClevelandOhio--
-Oklahoma CityOklahoma--
-TulsaOklahoma--
-PhiladelphiaPennsylvania--
-CharlestonSouth Carolina--
-ColumbiaSouth Carolina--
-GermantownTennessee--
-NashvilleTennessee--
-AustinTexas--
-GalvestonTexas--
-BurlingtonVermont--
-ChristiansburgVirginia--
-RichmondVirginia--
-BellevueWashington--
-MadisonWisconsin--
-MilwaukeeWisconsin--

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