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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Seoul National Univ. Hospital
Seoul, South Korea
Safety results
1. All AE/ADR during study 2. Physical examination including vital signs and ECG 3. Clinical laboratory results
Time frame: 48weeks
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
Time frame: 48weeks
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
Time frame: 48weeks
Change of individual parameter in ACR core set
Time frame: 48weeks
Change of individual parameter in DAS28
Time frame: 48weeks
Change of individual parameter in Rheumatoid factor
Time frame: 48 weeks
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