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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

July 29, 2009
July 29, 2009
April 2005
Not Provided
Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Hidradenitis Suppurativa Using Etanercept
Treatment of Hidradenitis Suppirativa With Etanercept Injection

Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with chronic HS
Hidradenitis Suppurativa
Drug: etanercept
etanercept 50 mg sc twice weekly
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.
Intervention: Drug: etanercept
Adams DR, Yankura JA, Fogelberg AC, Anderson BE. Treatment of hidradenitis suppurativa with etanercept injection. Arch Dermatol. 2010 May;146(5):501-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2008
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00949546
20031168
No
David R. Adams, Penn State Milton S. Hershey Medical Center
Penn State University
Amgen
Principal Investigator: David R Adams, MD, Pharm D Milton S. Hershey Medical Center
Penn State University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP