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
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Condition or disease | Intervention/treatment |
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Hidradenitis Suppurativa | Drug: etanercept |
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Treatment of Hidradenitis Suppirativa With Etanercept Injection |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Group/Cohort | Intervention/treatment |
---|---|
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.
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Drug: etanercept
etanercept 50 mg sc twice weekly |
- Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949546
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | David R Adams, MD, Pharm D | Milton S. Hershey Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00949546 History of Changes |
Other Study ID Numbers: |
20031168 |
First Posted: | July 30, 2009 Key Record Dates |
Last Update Posted: | November 24, 2017 |
Last Verified: | November 2017 |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Skin Diseases, Infectious Infection Suppuration Etanercept Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |