Hidradenitis Suppurativa
Conditions
Brief summary
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Interventions
DRUGetanercept
etanercept 50 mg sc twice weekly
Sponsors
Amgen
Penn State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician global assessment of HS of clear or mild at week 12 | Week 12 |
Countries
United States
Outcome results
None listed