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

NCT00570661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-05-04

Study results available
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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

Conditions

  • Active Systemic
  • Onset Juvenile Idiopathic Arthritis

Interventions

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.

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Nemanja Damjanov, MD, PhD · Institute of Rheumatology Belgrade

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-12
Primary Completion
2008-08-25
Completion
2013-06-10

Countries

  • Romania
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570661 on ClinicalTrials.gov