The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with methotrexate (MTX). There will be 3 treatment groups in the study as follows: CNTO148 50 mg group, CNTO 148 100 mg group, and Placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
311
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116.
ACR 20% response
Time frame: Weel 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
Asahikawa, Japan
Unnamed facility
Ayauta, Japan
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Azumino, Japan
Unnamed facility
Chiba, Japan
Unnamed facility
Fuchū, Japan
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Fukui, Japan
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Fukuoka, Japan
Unnamed facility
Fukushima, Japan
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Gifu, Japan
Unnamed facility
Goshogawara, Japan
...and 57 more locations