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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical

Criteria

Inclusion Criteria:

• Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301

• Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study

• Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301

• Willing to give written informed consent

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study

• ALT or AST > ULNⅹ2.5

• Platelet count < 100ⅹ103/ μL

• WBC < 3,000/mm3

• Absolute neutrophil count < 1,000/mm3

• Absolute lymphocyte count < 500/mm3

• Total bilirubin > ULNⅹ2