24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, Taiwan
Chang Gung Memorial Hospital -Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Proportion of patients with an American College of Rheumatology 70 (ACR70) response
Time frame: at week 24
Proportion of patients with ACR50 response
Time frame: at week 24
Proportion of patients with ACR20 response
Time frame: at week 24
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Time frame: at baseline and week 24
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Time frame: at baseline and week 24
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Time frame: at week 24
Adverse event incidence
Time frame: from baseline to week 24
Mean change from baseline to evaluation visits in vital signs
Time frame: from baseline to week 24
Change in Electrocardiogram. From baseline to evaluation visits
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative hematological exam results.
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results.
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
...and 2 more locations
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Time frame: from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Time frame: from baseline to week 24