Status:
COMPLETED
Etanercept in Hidradenitis Suppurativa
Lead Sponsor:
University of Athens
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
The rationale of the protocol is based on the reported beneficiary results of case-patients by the administration of other anti-TNF drug (infliximab) in separate cases on the grounds of a probable aut...
Detailed Description
Hidradenitis suppurativa is a disorder of unknown etiology. Various hypotheses have implicated obesity, diabetes mellitus, genetic predisposition and tight clothing as probable contributing factors. A...
Eligibility Criteria
Inclusion
- Definitive diagnosis of hidradenitis suppurativa
- Age \> 16 years
- No presence of infections other then hidradenitis suppurativa.
- Disease activity index \> 20
- Signed informed consent
Exclusion
- Received any live (attenuated) vaccines within 4 weeks of enrolment visits
- Has a history of anti-cardiolipin antibodies associated with a thrombotic event
- Has a history of confirmed blood dyscrasias
- Has a significant active infection or any underlying diseases that could predispose subjects to infections (ie. Advanced or poorly controlled diabetes).
- Demonstrates liver function abnormality \[SCOT, SGPT\>2 X upper limit of normal\]
- Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma) within 5 years of entering the enrollement period incompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of HIV infection, or central nervous system demyelinating events suggestive of multiple sclerosis.
- Has a history of known liver cirrhosis, fibrosis or fatty liver
- Has a history of any viral hepatitis
- Has renal disease (creatinine level \> 175μmol/L)
- Has leucopenia (WBC \<3500 x 106 /L)
- Has Thrombocytopenia (PLT's \< 125 x 109 /L)
- Is pregnant or breast feeding.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00329823
Start Date
September 1 2005
End Date
May 1 2006
Last Update
May 25 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
4th Department of Internal Medicine, University of Athens, Medical School
Athens, Greece, 124 64