Skip to main content
OpenTrials
Completed

NCT Number: NCT00949546

Treatment of Hidradenitis Suppurativa Using Etanercept

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

etanercept 50 mg sc twice weekly

Primary outcomes

  1. Physician global assessment of HS of clear or mild at week 12

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Amgen

Registry information

Official study title

Treatment of Hidradenitis Suppirativa With Etanercept Injection

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2009
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.