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Etanercept for Treatment of Hidradenitis

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00107991
First received: April 11, 2005
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a dose of 50 mg per week in patients with psoriasis.

The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis. Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life.

The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF- α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in the signs and symptoms of hidradenitis.

This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up. Approximately 21 subjects will participate at the University of Pennsylvania.

Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years.


Condition Intervention Phase
Hidradenitis Suppurativa
Drug: etanercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Physician's Global Assessment Score - Response Rate (Percentage) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.

    PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.



Secondary Outcome Measures:
  • Number of Lesions (Response Rate - Percentage) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.

  • Patient Global Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:

    Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)


  • Patient's Pain Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Reponse rate was calculated as the percentage of patients classified as responders.

  • Dermatology Life Quality Index Score (DLQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.

    Response rates were calculated as the percentage of participants achieving a response.



Enrollment: 15
Study Start Date: April 2005
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
Open-label treatment with etanercept 50 mg/week subcutaneous injection
Drug: etanercept
etanercept 50 mg/week subcutaneous injection
Other Name: Enbrel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be able to give informed consent.
  • Severe hidradenitis suppurativa clinically confirmed by the investigator and defined as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus track and scar formation (e.g. Stage II or III disease) that has not responded to previous standard therapies such as topical or oral antibiotics, or intralesional injections of steroids.
  • Age 18 or older.
  • Willingness to use at least one form of effective contraception during the study period and for one month after discontinuation of etanercept if female and of child bearing capacity or if male. If the patient elects to use a hormonal form of contraception then the patient must be on the same form of hormonal contraception for 90 days prior to the start of Etanercept and must plan to continue using the same form of hormonal contraception for the duration of the study (e.g. until week 18).

Exclusion Criteria:

  • Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30 days prior to day 0 or at any time during the study treatment period.
  • Use of systemic immunosuppressants within 90 days prior to day 0 of this study.
  • Use of an investigational medication 90 days prior to day 0 of this study.
  • Use of a live vaccine 90 days prior to day 0 of this study.
  • Any previous use of TNF- α inhibitors.
  • If using a hormonal form of contraception, the patient will be excluded if they have not used the same form of hormonal contraception for 90 days prior to the start of the etanercept (e.g. day 0) or are not willing to continue the use of the same form of hormonal contraception for the duration of the study.
  • Active infection within 30 days of day 0 of the study that is moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating with inability to work or perform normal daily activities) or requires treatment with antibiotics.
  • History of tuberculosis or other mycobacterial disease or positive screening visit PPD (≥ 5 mm).
  • Known history of an immuno-suppressing disease (e.g. HIV)
  • Clinically significant abnormality in liver function, renal function, chemistry panel or CBC (AST or ALT ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 2.0 mg/dL) or severe co-morbidities defined as diabetes mellitus requiring insulin, congestive heart failure, history of myocardial infarction, unstable angina, uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure >110 mmHg), severe pulmonary disease (requiring oxygen therapy), history of cancer within 5 years (other than resected basal cell or squamous cell carcinoma and in situ cervical cancer), known history of active hepatitis B or C or HIV infection, history of demyelinating diseases or lupus.
  • Pregnancy or lactation
  • History of alcohol or drug abuse within 12 months of screening visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107991

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Joel Gelfand, MD University of Pennsylvania
  More Information

Publications:
Responsible Party: Joel Gelfand, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00107991     History of Changes
Other Study ID Numbers: 802687, 0305
Study First Received: April 11, 2005
Results First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Suppuration
Sweat Gland Diseases
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014