NCT01256736

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
DRUG	DMARDs	DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-12-01
• Completion: 2013-11-01
• First posted: 2010-12-09
• Last updated: 2013-11-20

Locations

1 site across 1 country: South Korea