This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
11
8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
Unnamed facility
Rio de Janeiro, Rio de Janeiro, Brazil
Unnamed facility
Rio de Janeiro, Rio de Janeiro, Brazil
Unnamed facility
Porto Alegre, Rio Grande do Sul, Brazil
Unnamed facility
São Paulo, São Paulo, Brazil
Long-term safety: Incidence of adverse events
Time frame: approximately 3 years
Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)
Time frame: approximately 3 years
Proportion of patients achieving inactive disease/clinical remission
Time frame: approximately 3 years
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