Overview

Etanercept in Hidradenitis Suppurativa

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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 autoimmune predisposition of the disease. The objective of this study is to clarify the potency of etanercept for the therapy of hidradenitis suppurativa.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Athens
Treatments:
Etanercept
Criteria
Inclusion Criteria:

- Definitive diagnosis of hidradenitis suppurativa

- Age > 16 years

- No presence of infections other then hidradenitis suppurativa.

- Disease activity index > 20

- Signed informed consent

Exclusion Criteria:

- 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.