592
Participants
Start Date
September 30, 2009
Primary Completion Date
March 31, 2011
Study Completion Date
February 28, 2013
Golimumab
Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).
Placebo
Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.
methotrexate (MTX)
Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.
Daytona Beach
Miami
Palm Harbor
Moline
Wheaton
Worcester
Lincoln
Cincinnati
Lubbock
Buenos Aires
Córdoba
Rosario
San Juan
San Miguel de Tucumán
Santa Fe
Cairns
Maroochydore
Melbourne
Woodville
Woolloongabba
Antioquia
Barranquilla
Bogotá
Cali Valley Del Cauca
Medellín
Budapest
Debrecen
Eger
Győr
Gyula
Szombathely
Veszprém
Alytus
Kaunas
Klaipėda
Šiauliai
Vilnius
George Town
Ipoh
Johor Bahru
Kota Kinabalu
Kuantan
Kuching
Precinct 7
Selangor Darul Ehasan
Seremban
Guadalajara
León
Mexico City
México
Monterrey
Auckland
Takapuna Auckland
Timaru
Bialystok
Bydgoszcz
Działdowo
Elblag
Katowice
Lublin
Poznan
Sopot
Szczecin
Warsaw
Wroclaw
Włoszczowa
Chelyabinsk
Krasnoyarsk
Moscow
Petrozavodsk
Saint Petersburg
Saratov
Yekaterinburg
Anyang
Daegu
Daejeon
Incheon
Pusan
Seoul
Donetsk
Ivano-Frankivsk
Kharkiv
Kyiv
Odesa
Simferopol
Ternopil
Vinnitsa
Zaporizhzhya
Lead Sponsor
Collaborators (1)
Schering-Plough
INDUSTRY
Centocor, Inc.
INDUSTRY