Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT00570661
Brief 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.
Study:
NCT00570661
Study Brief:
Protocol Section:
NCT00570661