Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Phase 2 Completed 221 enrolled UCB Pharma

RandomizedFactorialDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.

Timeline

Start: 2010-11
Primary completion: 2012-06
Completion: 2012-06

Outcome

Met primary endpoint

paper OKZ treatment produced significantly greater reductions in DAS28(CRP) from baseline levels at Week 12, compared to PBO (p<0.001) PMID 24641941 ↗

Publications

Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olokizumab	Monoclonal antibody	60 mg	Subcutaneous
Subject	Olokizumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Olokizumab	Monoclonal antibody	240 mg	Subcutaneous
Comparator	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous