A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Biotech, Inc.
Study ID
NCT01550744
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab 45 mg — DRUG
    Form = Injection, route = subcutaneous
  • Ustekinumab 90 mg — DRUG
    Form = Injection, route = subcutaneous
  • Placebo — DRUG
    Form = Injection, route = subcutaneous

Study Details

The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.

Key Dates

Start date
Mar 31, 2012
Status verified
Dec 2016
Primary completion
May 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Group 1: Approved q12w maintenance regimen
    Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind
  • Experimental: Group 2: Subject-tailored fixed-interval maintenance regimen
    Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.

Primary Outcome Measure

The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) [ Time Frame: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) ]

Locations (40)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-BakersfieldCalifornia--
-IrvineCalifornia--
-Los AngelesCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-Santa MonicaCalifornia--
-DenverColorado--
-BridgeportConnecticut--
-Coral GablesFlorida--
-Saint AugustineFlorida--
-TampaFlorida--
-ChicagoIllinois--
-IndianapolisIndiana--
-PlainfieldIndiana--
-LouisvilleKentucky--
-New OrleansLouisiana--
-BostonMassachusetts--
-TroyMichigan--
-FridleyMinnesota--
-St LouisMissouri--
-HendersonNevada--
-LebanonNew Hampshire--
-East WindsorNew Jersey--
-New YorkNew York--
-The BronxNew York--
-WilliamsvilleNew York--
-GahannaOhio--
-NormanOklahoma--
-PortlandOregon--
-PittsburghPennsylvania--
-YardleyPennsylvania--
-JohnstonRhode Island--
-NashvilleTennessee--
-ArlingtonTexas--
-DallasTexas--
-Salt Lake CityUtah--
-NorfolkVirginia--
-SpokaneWashington--
-ClarksburgWest Virginia--

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease

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