Conditions: Juvenile Idiopathic Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drugs (NSAIDs) intervention 4: methotrexate intervention 5: corticosteroids
Intervention descriptions: intervention 1: 8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule. intervention 2: iv every 2 weeks for 12 weeks intervention 3: as prescribed intervention 4: as prescribed intervention 5: orally, as prescribed

Protocol document: