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Treatment of Hidradenitis Suppurativa Using Etanercept

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ClinicalTrials.gov Identifier: NCT00949546
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Penn State University

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

Condition or disease Intervention/treatment
Hidradenitis Suppurativa Drug: etanercept

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Hidradenitis Suppirativa With Etanercept Injection
Study Start Date : April 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: etanercept
etanercept 50 mg sc twice weekly


Outcome Measures
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Primary Outcome Measures :
  1. Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with chronic HS
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949546


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Amgen
Investigators
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Principal Investigator: David R Adams, MD, Pharm D Milton S. Hershey Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00949546     History of Changes
Other Study ID Numbers: 20031168
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors