drugset / Trial / NCT01009242

To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

NCT01009242

Phase 1/2 Completed 40 enrolled UCB Pharma
RandomizedParallel-groupDouble-blindBasic science

Summary

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

Timeline

Start
2009-10
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Olokizumab Monoclonal antibody 0.1 mg/kg Intravenous
Subject Olokizumab Monoclonal antibody 1 mg/kg Intravenous
Background Methotrexate Small molecule

Indications