Treatment of Hidradenitis Suppurativa Using Etanercept

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Hidradenitis Suppurativa

Treatments: Drug: etanercept

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00949546

20031168

Details and patient eligibility

About

Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

placebo controlled

Description:

A randomized, double-blind trial of 3 months duration comparing etanercept 50 mg sc twice weekly to placebo in 20 patients with HS. Patients will be randomized with equal allocation to the two treatment groups.

Treatment:

Drug: etanercept