Treatment of Hidradenitis Suppurativa Using Etanercept

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00949546
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention
Hidradenitis Suppurativa
Drug: etanercept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Hidradenitis Suppirativa With Etanercept Injection

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2005
Study Completion Date: January 2008
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949546

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Amgen
Investigators
Principal Investigator: David R Adams, MD, Pharm D Milton S. Hershey Medical Center
  More Information

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David R. Adams, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00949546     History of Changes
Other Study ID Numbers: 20031168
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014