A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Rheumatoid Arthritis
Interventions
DRUG

CNTO 148

50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.

DRUG

Placebo

Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.

DRUG

Methotrexate (MTX)

6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.

Trial Locations (65)

Unknown

Asahi

Asahikawa

Azumino

Chiba

Fukui

Fukuoka

Fukushima

Gifu

Goshogawara

Hachiōji

Hamamatsu

Higashi-Hiroshima

Hiki

Hiroshima

Hitachi

Iruma

Izumisano

Izumo

Kamakura

Katō

Kawachi-Nagano

Kawagoe

Kawasaki

Kita-Gun

Kitakyushu

Kitamoto

Kobe

Kumamoto

Kyoto

Matsue

Matsumoto

Matsuyama

Nagano

Nagasaki

Nagoya

Narashino

Nishinomiya

Ohta-Ku

Osaka

Ōita

Ōsaki

Sagamihara

Saitama

Sapporo

Sasebo

Sendai

Shimotsuga

Shimotsuke

Shinjuku

Shinjuku-Ku

Shizuoka

Suita

Tokorozawa

Tokushima

Tokyo

Toshima-Ku

Toyama

Toyoake

Toyohashi

Tsu

Tsukuba

Tsukubo

Ube

Yokohama

Yufu

All Listed Sponsors
collaborator

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

lead

Janssen Pharmaceutical K.K.

INDUSTRY