A Phase 3 interventional study of CNTO 148 and Placebo in Rheumatoid Arthritis, sponsored by Janssen Pharmaceutical K.K.. Completed at 67 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 311 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Drug: CNTO 148
Drug: CNTO 148
Drug: Placebo
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Also known as: Golimumab
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 study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Golimumab