Status:
UNKNOWN
The Efficacy and Safety of ITF2357 in AIS
Lead Sponsor:
Radboud University Medical Center
Conditions:
Autoinflammatory Syndromes
HIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 r...
Detailed Description
Rationale: Autoinflammatory syndromes (AIS) are a group of disorders characterized by recurrent episodes of inflammation. This occurs in the absence of autoantibodies and antigen specific T cells. To ...
Eligibility Criteria
Inclusion
- 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
- Age \< 18 years
- Pregnancy and lactation
- Increased risk for infection or current infection
- Renal failure (GFR\<30ml/1.73m2/min)
- Pre-existing malignancy
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00442182
Start Date
September 1 2006
Last Update
March 1 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands, 6500 HB