NCT00442182

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 28, 2007

Last Update Submit

February 28, 2007

Conditions

Autoinflammatory SyndromesHIDSTRAPSSchnitzler's Syndrome

Keywords

autoinflammatory syndromes

Outcome Measures

Primary Outcomes (2)

  • clinical complete remission

  • number of days of illness

Secondary Outcomes (1)

  • side effects

Interventions

ITF2357DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Pregnancy and lactation
  • Increased risk for infection or current infection
  • Renal failure (GFR\<30ml/1.73m2/min)
  • Pre-existing malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre Nijmegen

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Schnitzler Syndrome

Interventions

givinostat hydrochloride

Condition Hierarchy (Ancestors)

Monoclonal Gammopathy of Undetermined SignificanceParaproteinemiasImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jos WM van der Meer, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelien J Bodar, MD

CONTACT

0031 24 3617276e.bodar@aig.umcn.nl

Jos WM van der Meer, MD PhD

CONTACT

0031 24 3618819j.vandermeer@aig.umcn.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

September 1, 2006

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

NL(1)