A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in
patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate
clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be
randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg,
or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will
be continued throughout. After 12 weeks of double-blind treatment, all patients will have the
option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra
for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which,
for patients who meet specific criteria, an optional alternative dosing schedule decreasing
the study drug administration frequency will be introduced. Anticipated time on study
treatment is up to 5 years.