Treatment of Hidradenitis Suppurativa Using Etanercept
This study has been completed.
Sponsor:
Penn State University
Collaborator:
Amgen
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00949546
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
| Condition | Intervention |
|---|---|
|
Hidradenitis Suppurativa |
Drug: etanercept |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment of Hidradenitis Suppirativa With Etanercept Injection |
Resource links provided by NLM:
Genetics Home Reference related topics:
hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Penn State University:
Primary Outcome Measures:
- Physician global assessment of HS of clear or mild at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | April 2005 |
| Study Completion Date: | January 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Drug: etanercept
etanercept 50 mg sc twice weekly
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Patients with chronic HS
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949546
Locations
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
Sponsors and Collaborators
Penn State University
Amgen
Investigators
| Principal Investigator: | David R Adams, MD, Pharm D | Milton S. Hershey Medical Center |
More Information
No publications provided by Penn State University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David R. Adams, Penn State Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00949546 History of Changes |
| Other Study ID Numbers: | 20031168 |
| Study First Received: | July 29, 2009 |
| Last Updated: | July 29, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hidradenitis Hidradenitis Suppurativa Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Skin Diseases, Infectious Infection Suppuration TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013