drugset / Trial / NCT01242488

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

NCT01242488

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications