Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis

Inclusion criteria

• ✓. Established diagnosis of Systemic SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
• ✓. Active disease for at least one month prior to enrolment as defined by the following criteria:
• ✓. Age at enrolment between 2 and 25 years
• ✓. Age at first SOJIA diagnosis \< 16 years
• ✓. Previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to \>= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
• ✓. In case of concomitant methotrexate treatment, it has to be on stable dose \>= 10mg/m2 weekly for al least 4 weeks before pt enrollment
• ✓. Previous treatment with biologics, if any, during at least three months without satisfactory effect or with drug intolerability, discontinued for at least the period specified below before patient's enrolment:
• ✓. Other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half lives