Treatment of Hidradenitis Suppurativa Using Etanercept

NCT ID: NCT00949546

Last Updated: 2017-11-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

etanercept 50 mg sc twice weekly

Interventions

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etanercept

etanercept 50 mg sc twice weekly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 20479297 (View on PubMed)

Other Identifiers

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20031168

Identifier Type: -

Identifier Source: org_study_id