A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Centocor, Inc.
Study ID
NCT00771667
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

Key Dates

Start date
Dec 31, 2008
Status verified
Mar 2013
Primary completion
May 31, 2010
Completion
Dec 31, 2010

Study Design

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

Arms

  • Placebo Comparator: Placebo (IP)
  • Experimental: Ustekinumab 1mg/kg (IP)
  • Experimental: Ustekinumab 3 mg/kg (IP)
  • Experimental: Ustekinumab 6 mg/kg (IP)
  • Placebo Comparator: Placebo IV - Responder - Placebo SC (MP)
  • Placebo Comparator: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC
  • Placebo Comparator: Ustekinumab IV - Responder - Placebo SC (MP)
  • Experimental: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
  • Placebo Comparator: Ustekinumab IV - Nonresponder - Placebo SC (MP)
  • Experimental: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Primary Outcome Measure

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

Locations (88)

FacilityCityStateZIPSite coordinators
-MobileAlabama--
-ScottsdaleArizona--
-La JollaCalifornia--
-Los AngelesCalifornia--
-RosevilleCalifornia--
-San CarlosCalifornia--
-San FranciscoCalifornia--
-EnglewoodColorado--
-LakewoodColorado--
-LittletonColorado--
-HamdenConnecticut--
-GainesvilleFlorida--
-HollywoodFlorida--
-JacksonvilleFlorida--
-MiamiFlorida--
-NaplesFlorida--
-Panama CityFlorida--
-Pembroke PinesFlorida--
-Port CharlotteFlorida--
-Port OrangeFlorida--
-South MiamiFlorida--
-TampaFlorida--
-Vero BeachFlorida--
-Winter ParkFlorida--
-ZephyrhillsFlorida--
-AtlantaGeorgia--
-ColumbusGeorgia--
-DecaturGeorgia--
-MaconGeorgia--
-NewnanGeorgia--
-Arlington HeightsIllinois--
-ChicagoIllinois--
-EvanstonIllinois--
-IndianapolisIndiana--
-CliveIowa--
-PrattKansas--
-LexingtonKentucky--
-LouisvilleKentucky--
-BaltimoreMaryland--
-Chevy ChaseMaryland--
-TowsonMaryland--
-BostonMassachusetts--
-BurlingtonMassachusetts--
-WorcesterMassachusetts--
-Ann ArborMichigan--
-ChesterfieldMichigan--
-DetroitMichigan--
-TroyMichigan--
-RochesterMinnesota--
-Ocean SpringsMississippi--
-MexicoMissouri--
-LebanonNew Hampshire--
-Egg HarborNew Jersey--
-Great NeckNew York--
-New YorkNew York--
-PoughkeepsieNew York--
-SetauketNew York--
-Stony BrookNew York--
-Chapel HillNorth Carolina--
-CharlotteNorth Carolina--
-GreenvilleNorth Carolina--
-KinstonNorth Carolina--
-New BernNorth Carolina--
-RaleighNorth Carolina--
-BeavercreekOhio--
-CincinnatiOhio--
-ClevelandOhio--
-DaytonOhio--
-Oklahoma CityOklahoma--
-PhiladelphiaPennsylvania--
-CharlestonSouth Carolina--
-ColumbiaSouth Carolina--
-ChattanoogaTennessee--
-NashvilleTennessee--
-AustinTexas--
-HoustonTexas--
-LewisvilleTexas--
-San AntonioTexas--
-OgdenUtah--
-Salt Lake CityUtah--
-BurlingtonVermont--
-CharlottesvilleVirginia--
-NorfolkVirginia--
-BellevueWashington--
-LakewoodWashington--
-SeattleWashington--
-TacomaWashington--
-MadisonWisconsin--

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By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease

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