CompletedPhase 2

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

Romania, Serbia17 participantsStarted 2006-09-12

Plain-language 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

Who can participate

Age range

2 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Established diagnosis of Systemic SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
. Active disease for at least one month prior to enrolment as defined by the following criteria:
. Age at enrolment between 2 and 25 years
. Age at first SOJIA diagnosis \< 16 years
. Previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to \>= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
. In case of concomitant methotrexate treatment, it has to be on stable dose \>= 10mg/m2 weekly for al least 4 weeks before pt enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients Completing Week 12 of Treatment

Timeframe: At week 12

Trial details

NCT IDNCT00570661

SponsorItalfarmaco

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08-25

Results submitted2021-02-08

View on ClinicalTrials.gov More Active Systemic trials

Plain-language summary

Who can participate

Age range

2 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Established diagnosis of Systemic SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
. Active disease for at least one month prior to enrolment as defined by the following criteria:
. Age at enrolment between 2 and 25 years
. Age at first SOJIA diagnosis \< 16 years
. Previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to \>= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
. In case of concomitant methotrexate treatment, it has to be on stable dose \>= 10mg/m2 weekly for al least 4 weeks before pt enrollment

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria