102
Participants
Start Date
October 15, 2015
Primary Completion Date
May 15, 2017
Study Completion Date
March 13, 2019
Ustekinumab IV
Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.
Placebo Infusion
Placebo intravenously at Week 0.
Placebo SC
Placebo subcutaneously at Weeks 8 and 16.
Ustekinumab SC
Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)
Concomitant Medication
Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
Huntsville
Beverly Hills
Tampa
Lansing
Manhasset
New York
Syracuse
Tulsa
Duncansville
Philadelphia
Charleston
Jackson
Buenos Aires
Ciudad de San Miguel de Tucuman
San Juan
Adelaide
Camberwell
Heidelberg
Liverpool
Nedlands
Berlin
Cologne
Frankfurt
Budapest
Debrecen
Szeged
Zalaegerszeg
Chihuahua City
Guadalajara
León
México
Bydgoszcz
Poznan
Szczecin
Wroclaw
Barcelona
Madrid
Málaga
Santiago de Compostela
Seville
Kaohsiung City
Taichung
Taoyuan District
Janssen Research & Development, LLC
INDUSTRY