Overview

Treatment of Hidradenitis Suppurativa Using Etanercept

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Penn State University
Collaborator:
Amgen
Treatments:
Etanercept
Criteria
Inclusion Criteria:

- Chronic HS for > 6months defined as tender and/or painful, red nodules and/or plaques
(confluent nodules) with or without scarring, foul odor, or draining sinuses
clinically with HS

- Localizes to skin folds including any of axillx, breast, abdomen and groin

- active disease

- Negative pregnancy test within 7 days before the first dose of study drug

- Sexually active subjects of childbearing potential must agree to use medically
acceptable form of contraception during screening and throughout the study

Exclusion Criteria:

- Concurrent active infection including tuberculosis

- Concurrent therapy or therapy 30 days prior with systemic corticosteroids, systemic
immunosuppressants, systemic retinoids or ant-TNF agents

- Severe comorbidities (diabetes mellitus requiring insulin, Q F of any severity, MI,
unstable angina eectoris, uncontrolled hypertension, oxygendependent severe pulmonary
disease, history of cancer *thin 5_ years except cutaneous basal cell or squamous cell
carcinoma or in situ cervical carcinoma, history of TB or TB exposure, chronic
hepatitis B or C, SLE, history of multiple sclerosis, transverse myelitis, optic
neuritis or epilepsy

- Currently enrolled or enrolled within 90 days prior in any trial for treatment of HS

- Known HIV positive

- Contraindication to etanercept as defined in package insert