NCT01463059

Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo solution for injection, administered as subcutaneous injections
BIOLOGICAL	Olokizumab 60 mg	Olokizumab 60 mg solution for injection, administered as subcutaneous injections
BIOLOGICAL	Olokizumab 120 mg	Olokizumab 120 mg solution for injection, administered as subcutaneous injections
BIOLOGICAL	Olokizumab 240 mg	Olokizumab 240 mg solution for injection, administered as subcutaneous injections

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-11-01
• Last updated: 2013-03-25

Locations

39 sites across 3 countries: Japan, South Korea, Taiwan