Treatment of Hidradenitis Suppurativa Using Etanercept
1 other identifier
observational
20
1 country
1
Brief Summary
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedNovember 24, 2017
November 1, 2017
2.8 years
July 29, 2009
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Physician global assessment of HS of clear or mild at week 12
Week 12
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with chronic HS
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- Amgencollaborator
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
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.
PMID: 20479297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Adams, MD, Pharm D
Milton S. Hershey Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
April 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
November 24, 2017
Record last verified: 2017-11