Status:
COMPLETED
Treatment of Hidradenitis Suppurativa Using Etanercept
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Amgen
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Brief Summary
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00949546
Start Date
April 1 2005
End Date
January 1 2008
Last Update
November 24 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033