Status:
COMPLETED
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
JW Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ac...
Eligibility Criteria
Inclusion
- 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- Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01256736
Start Date
March 1 2010
End Date
November 1 2013
Last Update
November 20 2013
Active Locations (1)
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1
Seoul National Univ. Hospital
Seoul, South Korea, 110-744