Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2005-04-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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placebo controlled
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.
etanercept
etanercept 50 mg sc twice weekly
Interventions
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etanercept
etanercept 50 mg sc twice weekly
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Penn State University
OTHER
Responsible Party
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Principal Investigators
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David R Adams, MD, Pharm D
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Adams DR, Yankura JA, Fogelberg AC, Anderson BE. Treatment of hidradenitis suppurativa with etanercept injection. Arch Dermatol. 2010 May;146(5):501-4. doi: 10.1001/archdermatol.2010.72.
Other Identifiers
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20031168
Identifier Type: -
Identifier Source: org_study_id