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Etanercept in Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Etanercept sc 50mg per week for 12 weeks
Sponsored by
University of Athens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, etanercept

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Definitive diagnosis of hidradenitis suppurativa Age > 16 years No presence of infections other then hidradenitis suppurativa. Disease activity index > 20 Signed informed consent Exclusion Criteria: Received any live (attenuated) vaccines within 4 weeks of enrolment visits Has a history of anti-cardiolipin antibodies associated with a thrombotic event Has a history of confirmed blood dyscrasias Has a significant active infection or any underlying diseases that could predispose subjects to infections (ie. Advanced or poorly controlled diabetes). Demonstrates liver function abnormality [SCOT, SGPT>2 X upper limit of normal] Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma) within 5 years of entering the enrollement period incompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of HIV infection, or central nervous system demyelinating events suggestive of multiple sclerosis. Has a history of known liver cirrhosis, fibrosis or fatty liver Has a history of any viral hepatitis Has renal disease (creatinine level > 175μmol/L) Has leucopenia (WBC <3500 x 106 /L) Has Thrombocytopenia (PLT's < 125 x 109 /L) Is pregnant or breast feeding.

Sites / Locations

  • 4th Department of Internal Medicine, University of Athens, Medical School

Outcomes

Primary Outcome Measures

Endpoints :
The disease activity index based on a calculated score.
The sum of the [diameter X severity] for each affected area.
Patient's global assessment of disease activity scores based on a VAS scale
of 1-10.
The number of newly presented lesions.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2006
Last Updated
May 23, 2006
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT00329823
Brief Title
Etanercept in Hidradenitis Suppurativa
Official Title
A Phase 2 Study of the Safety and Efficacy of Etanercept for the Therapy of Hydradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Athens

4. Oversight

5. Study Description

Brief Summary
The rationale of the protocol is based on the reported beneficiary results of case-patients by the administration of other anti-TNF drug (infliximab) in separate cases on the grounds of a probable autoimmune predisposition of the disease. The objective of this study is to clarify the potency of etanercept for the therapy of hidradenitis suppurativa.
Detailed Description
Hidradenitis suppurativa is a disorder of unknown etiology. Various hypotheses have implicated obesity, diabetes mellitus, genetic predisposition and tight clothing as probable contributing factors. Although patients are presenting with suppuration of their lesions, typical furuncles are absent (1). Administration of antibiotics offers transient relief of symptoms whereas therapies like androgens, isotretinoin and methotrexate have failed to disclose clinical benefit (2). More than thirty out-patients with hidradenitis suppurativa are followed up at the clinic of the "Immunology of Infectious Diseases" of the ATTIKON University Hospital of Athens. None of them is presenting with diabetes mellitus and their CD4 cell counts are within normal limits. However, their testing for the function of monocytes is often abnormal. This test involves the isolation of monocytes and the ex vivo release of pro-inflammatory cytokines both without and after stimulation by bacterial endotoxins and lipoteichoic acid. Results have shown an increased baseline secretion and poor response of monocytes after stimulation. Case reports with limited number of patients have disclosed clinical benefit of an other anti-TNF drug (infliximab) after one or two doses administration in hidradenitis suppurativa. These reports involve retrospective results of five patients (3) or single cases (4,5). The rationale of the administration of etanercept in hidradenitis suppurativa is based on the following data: a) etanercept has been proven effective for the management of psoriasis that is considered a skin disorder with autoimmune background (6); and b) laboratory findings of our patients with hidradenitis suppurativa point towards an altered immune response of their adaptive immunity (7). Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Elevated levels of TNF are also found in the synovium of patients with psoriatic arthritis. Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumor necrosis factor receptors (TNFRs). Both TNFRs exist naturally in membrane-bound and soluble forms. Soluble TNFRs are thought to regulate TNF biological activity. TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs. Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors. In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life. OBJECTIVE The objective of this study is to clarify the potency of etanercept for the therapy of hidradenitis suppurativa. RATIONALE The rationale of the protocol is based on the reported beneficiary results of case-patients by the administration of other anti-TNF drug (infliximab) in separate cases on the grounds of a probable autoimmune predisposition of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis suppurativa, etanercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Etanercept sc 50mg per week for 12 weeks
Primary Outcome Measure Information:
Title
Endpoints :
Title
The disease activity index based on a calculated score.
Title
The sum of the [diameter X severity] for each affected area.
Title
Patient's global assessment of disease activity scores based on a VAS scale
Title
of 1-10.
Title
The number of newly presented lesions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Definitive diagnosis of hidradenitis suppurativa Age > 16 years No presence of infections other then hidradenitis suppurativa. Disease activity index > 20 Signed informed consent Exclusion Criteria: Received any live (attenuated) vaccines within 4 weeks of enrolment visits Has a history of anti-cardiolipin antibodies associated with a thrombotic event Has a history of confirmed blood dyscrasias Has a significant active infection or any underlying diseases that could predispose subjects to infections (ie. Advanced or poorly controlled diabetes). Demonstrates liver function abnormality [SCOT, SGPT>2 X upper limit of normal] Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma) within 5 years of entering the enrollement period incompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of HIV infection, or central nervous system demyelinating events suggestive of multiple sclerosis. Has a history of known liver cirrhosis, fibrosis or fatty liver Has a history of any viral hepatitis Has renal disease (creatinine level > 175μmol/L) Has leucopenia (WBC <3500 x 106 /L) Has Thrombocytopenia (PLT's < 125 x 109 /L) Is pregnant or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelos J Giamarellos-Bourboulis, MD, PhD
Organizational Affiliation
4th Department of Internal Medicine, University of Athens, Greece
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helen Giamarellou, MD, PhD
Organizational Affiliation
4th Department of Internal Medicine, University of Athens, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
4th Department of Internal Medicine, University of Athens, Medical School
City
Athens
ZIP/Postal Code
124 64
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
16536817
Citation
Cusack C, Buckley C. Etanercept: effective in the management of hidradenitis suppurativa. Br J Dermatol. 2006 Apr;154(4):726-9. doi: 10.1111/j.1365-2133.2005.07067.x.
Results Reference
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Etanercept in Hidradenitis Suppurativa

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