A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01369329
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Group 2 ustekinumab 130 mg — DRUG
    Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
  • Group 3: ustekinumab approximately 6 mg/kg — DRUG
    Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).
  • Group 1: Placebo — DRUG
    Form=solution for injection, route=intravenous use, in a single dose.

Study Details

This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

Key Dates

Start date
Jul 31, 2011
Status verified
Oct 2016
Primary completion
Jun 30, 2013
Completion
Jul 31, 2013

Study Design

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

Arms

  • Placebo Comparator: 001
    Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
  • Experimental: 002
    Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
  • Experimental: 003
    Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).

Primary Outcome Measure

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

Locations (67)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-Little RockArkansas--
-La JollaCalifornia--
-Los AngelesCalifornia--
-Redwood CityCalifornia--
-San CarlosCalifornia--
-San DiegoCalifornia--
-Lone TreeColorado--
-New HavenConnecticut--
-GainesvilleFlorida--
-JacksonvilleFlorida--
-WestonFlorida--
-Winter ParkFlorida--
-AtlantaGeorgia--
-DecaturGeorgia--
-MaconGeorgia--
-ChicagoIllinois--
-EvanstonIllinois--
-CliveIowa--
-LexingtonKentucky--
-LouisvilleKentucky--
-Baton RougeLouisiana--
-New OrleansLouisiana--
-BaltimoreMaryland--
-Chevy ChaseMaryland--
-TowsonMaryland--
-BostonMassachusetts--
-WorcesterMassachusetts--
-Ann ArborMichigan--
-ChesterfieldMichigan--
-NoviMichigan--
-TroyMichigan--
-RochesterMinnesota--
-Ocean SpringsMississippi--
-Lees SummitMissouri--
-UrbanaMissouri--
-Las VegasNevada--
-LebanonNew Hampshire--
-MarltonNew Jersey--
-MorristownNew Jersey--
-Great NeckNew York--
-New YorkNew York--
-RochesterNew York--
-Chapel HillNorth Carolina--
-CharlotteNorth Carolina--
-RaleighNorth Carolina--
-BeavercreekOhio--
-CincinnatiOhio--
-ClevelandOhio--
-Oklahoma CityOklahoma--
-BendOregon--
-SpringfieldOregon--
-HersheyPennsylvania--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-North CharlestonSouth Carolina--
-NashvilleTennessee--
-AustinTexas--
-HoustonTexas--
-TylerTexas--
-Salt Lake CityUtah--
-CharlottesvilleVirginia--
-ChesapeakeVirginia--
-NorfolkVirginia--
-Virginia BeachVirginia--
-SeattleWashington--
-MadisonWisconsin--

Find similar trials in Tucson, AZ

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

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