Treatment of Hidradenitis Suppurativa Using Etanercept

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: etanercept

• Registration Number: NCT00949546
• Lead Sponsor: Penn State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
placebo controlled	etanercept	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.

Primary Outcome Measures

Name	Time	Method
Physician global assessment of HS of clear or mild at week 12	Week 12

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States