The Efficacy and Safety of ITF2357 in AIS (NCT00442182) | Clinical Trial Compass
UnknownPhase 2
The Efficacy and Safety of ITF2357 in AIS
Netherlands20 participantsStarted 2006-09
Plain-language summary
Autoinflammatory syndromes (AIS) are a group of disorders characterized by recurrent episodes of inflammation.Although for the hereditary autoinflammatory diseases the genetic mutations are known it remains largely unclear how these mutations lead to recurrent inflammatory attacks. Treatment of the inflammatory symptoms remains a challenge. With beneficial responses reported during treatment with simvastatin, etanercept or anakinra in some but not all patients. ITF2357 is an orally active histon deacetylase inhibitor with a potent anti-inflammatory effect due to inhibition of pro-inflammatory cytokines (IL-1β, TNFα, IFNg, IL-6). We expect that ITF2357 is able to modify the clinical symptoms of AIS patients and induce clinical complete remission or a reduction in attack duration.
Who can participate
Age range
18 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:
* Autoinflammatory syndrome (hereditary or acquired)
* Age ³18 years
* Severe active disease (≥1 attack every eight weeks or continuous symptoms).
An attack will be defined as:
* Temperature of ≥38 ºC not otherwise explained.
* At least two other accompanying symptoms (e.g. joint pain, lymphadenopathy, skin lesions, abdominal symptoms)
* written informed consent obtained
Exclusion Criteria:
* Age \< 18 years
* Pregnancy and lactation
* Increased risk for infection or current infection
* Renal failure (GFR\<30ml/1.73m2/min)
* Pre-existing malignancy
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.