Hidradenitis SuppurativaPhase 2NCT00329823
Etanercept in Hidradenitis Suppurativa
A Phase 2 study testing Etanercept sc 50mg per week for 12 weeks in people with Hidradenitis Suppurativa, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Etanercept sc 50mg per week for 12 weeks
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2005to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Definitive diagnosis of hidradenitis suppurativa
- Age > 16 years
- No presence of infections other then hidradenitis suppurativa.
- Disease activity index > 20
- Signed informed consent
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
4th Department of Internal Medicine, University of Athens, Medical School
Athens, 124 64
About this study
Official title: A Phase 2 Study of the Safety and Efficacy of Etanercept for the Therapy of Hydradenitis Suppurativa
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Etanercept sc 50mg per week for 12 weeks
- Keywords
- Hidradenitis suppurativa, etanercept
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept sc 50mg per week for 12 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startSep 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Investigators
- Evangelos J Giamarellos-Bourboulis, MD, PhD, Study director, 4th Department of Internal Medicine, University of Athens, GreeceHelen Giamarellou, MD, PhD, Study chair, 4th Department of Internal Medicine, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329823
- Sponsor's protocol ID
- 2004-004555-19
- Other IDs
- 2004
- Status last verified
- May 2006
- First submitted
- 23 May 2006
- Last updated
- 25 May 2006
- Results posted
- No
Publications
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.
PubMed 16536817
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Safety and Efficacy of Etanercept for the Therapy of Hydradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00329823
- Acronym / sponsor ID
- 2004-004555-19
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, etanercept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- May 2006
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Definitive diagnosis of hidradenitis suppurativa
- Age > 16 years
- No presence of infections other then hidradenitis suppurativa.
- Disease activity index > 20
- Signed informed consent
Key exclusion criteria (12 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercept sc 50mg per week for 12 weeks | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2006.
- Background: PubMed 16536817Cusack 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.
Related trials for Hidradenitis Suppurativa
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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos J Giamarellos-Bourboulis, MD, PhD study director
4th Department of Internal Medicine, University of Athens, Greece
Helen Giamarellou, MD, PhD study chair
4th Department of Internal Medicine, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etanercept sc 50mg per week for 12 weeks in people with Hidradenitis Suppurativa, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoints :. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2006.