Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis
Status:
Completed
Trial end date:
2013-06-10
Target enrollment:
Participant gender:
Summary
This study has the following objectives:
Primary objective:
- To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with
inadequate response or intolerance to standard therapy with oral steroids and methotrexate,
with or without previously used biologic agents.
Secondary objectives:
- to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA
- to investigate the possibility of steroid dose tapering in patients with active SOJIA
during ITF2357 treatment
- to assess the effect of ITF2357 on levels of circulating cytokines
- to assess the pharmacokinetic properties of ITF2357