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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

Tracking Information
First Submitted Date July 29, 2009
First Posted Date July 30, 2009
Last Update Posted Date November 24, 2017
Study Start Date April 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2009)
Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00949546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Hidradenitis Suppurativa Using Etanercept
Official Title Treatment of Hidradenitis Suppirativa With Etanercept Injection
Brief Summary Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with chronic HS
Condition Hidradenitis Suppurativa
Intervention Drug: etanercept
etanercept 50 mg sc twice weekly
Study Groups/Cohorts 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2009)
20
Original Actual Enrollment Same as current
Actual Study Completion Date January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00949546
Other Study ID Numbers 20031168
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Penn State University
Study Sponsor Penn State University
Collaborators Amgen
Investigators
Principal Investigator: David R Adams, MD, Pharm D Milton S. Hershey Medical Center
PRS Account Penn State University
Verification Date November 2017