A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

Phase 3 Completed 311 enrolled Janssen Pharmaceutical K.K. Tanabe Pharma Corporation · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2008-05
Primary completion: 2011-10
Completion: 2011-10

Outcome

Met primary endpoint

paper Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 PMID 22984173 ↗

paper (20/105 (19.0%); p<0.0001 for both) PMID 22984173 ↗

Publications

Results Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-MONO study group. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013 Sep 1;72(9):1488-95. doi: 10.1136/annrheumdis-2012-201796. Epub 2012 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Golimumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Golimumab	Monoclonal antibody	100 mg	Subcutaneous