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

Phase 3 Completed 269 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 Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Timeline

Start: 2008-05
Primary completion: 2011-12
Completion: 2011-12

Outcome

Met primary endpoint

paper Group 2 (72.1%, 62/86) and Group 3 (74.7%, 65/87) compared with Group 1 (27.3%, 24/88; p<0.0001 for all comparisons). PMID 22121129 ↗

Publications

Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-FORTH Study Group. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012 Jun;71(6):817-24. doi: 10.1136/ard.2011.200317. Epub 2011 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Golimumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Golimumab	Monoclonal antibody	100 mg	Subcutaneous
Background	Methotrexate	Small molecule	6 mg	Oral
Background	Methotrexate	Small molecule	8 mg	Oral