The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
269
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
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.
ACR 20% response
Time frame: Week 14
ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire)
Time frame: Week 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Asahi, Japan
Unnamed facility
Asahikawa, Japan
Unnamed facility
Azumino, Japan
Unnamed facility
Chiba, Japan
Unnamed facility
Fukui, Japan
Unnamed facility
Fukuoka, Japan
Unnamed facility
Fukushima, Japan
Unnamed facility
Gifu, Japan
Unnamed facility
Goshogawara, Japan
Unnamed facility
Hachiōji, Japan
...and 55 more locations