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Etanercept in Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT00329823
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : May 25, 2006
Sponsor:
Information provided by:
University of Athens

Tracking Information
First Submitted Date  ICMJE May 23, 2006
First Posted Date  ICMJE May 25, 2006
Last Update Posted Date May 25, 2006
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Etanercept in Hidradenitis Suppurativa
Official Title  ICMJE A Phase 2 Study of the Safety and Efficacy of Etanercept for the Therapy of Hydradenitis Suppurativa
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Drug: Etanercept sc 50mg per week for 12 weeks
Study Arms  ICMJE Not Provided
Publications * Cusack C, Buckley C. Etanercept: effective in the management of hidradenitis suppurativa. Br J Dermatol. 2006 Apr;154(4):726-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 23, 2006)
10
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00329823
Other Study ID Numbers  ICMJE 2004-004555-19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Evangelos J Giamarellos-Bourboulis, MD, PhD 4th Department of Internal Medicine, University of Athens, Greece
Study Chair: Helen Giamarellou, MD, PhD 4th Department of Internal Medicine, University of Athens, Greece
PRS Account University of Athens
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP