NCT00570661

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

Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

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

Detailed description

The present study has been designed in order to evaluate safety and tolerability of 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, and to have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA. ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults, which so far has been proven to be free of any relevant safety concerns both in healthy volunteers and in patients.

Conditions

• Active Systemic
• Onset Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	ITF2357	ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.

Timeline

• Start date: 2006-09-12
• Primary completion: 2008-08-25
• Completion: 2013-06-10
• First posted: 2007-12-11
• Last updated: 2021-05-04
• Results posted: 2021-05-04

Locations

5 sites across 2 countries: Romania, Serbia