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

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

Timeline

Start

2006-09-12

Primary completion

2008-08-25

Completion

2013-06-10

Publications

• Vojinovic J, Damjanov N, D'Urzo C, Furlan A, Susic G, Pasic S, Iagaru N, Stefan M, Dinarello CA. Safety and efficacy of an oral histone deacetylase inhibitor in systemic-onset juvenile idiopathic arthritis. Arthritis Rheum. 2011 May;63(5):1452-8. doi: 10.1002/art.30238.
• Vojinovic J, Damjanov N. HDAC inhibition in rheumatoid arthritis and juvenile idiopathic arthritis. Mol Med. 2011 May-Jun;17(5-6):397-403. doi: 10.2119/molmed.2011.00030. Epub 2011 Feb 4.

Drugs

Indications