Treatment of Hidradenitis Suppurativa Using Etanercept

Hidradenitis Suppurativa Clinical Trial

Official title:

Treatment of Hidradenitis Suppirativa With Etanercept Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949546
• Other study ID #: 20031168
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: November 21, 2017
• Start date: April 2005
• Est. completion date: January 2008

Study information

• Verified date: November 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• etanercept
etanercept 50 mg sc twice weekly

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician global assessment of HS of clear or mild at week 12		Week 12