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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00329823 |
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Date of registration:
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23/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Etanercept in Hidradenitis Suppurativa
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Scientific title:
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A Phase 2 Study of the Safety and Efficacy of Etanercept for the Therapy of Hydradenitis Suppurativa |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00329823 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Greece
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Contacts
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Name:
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Evangelos J Giamarellos-Bourboulis, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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4th Department of Internal Medicine, University of Athens, Greece |
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Name:
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Helen Giamarellou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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4th Department of Internal Medicine, University of Athens, Greece |
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Key inclusion & exclusion criteria
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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.
Age minimum:
17 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hidradenitis Suppurativa
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Intervention(s)
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Drug: Etanercept sc 50mg per week for 12 weeks
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Primary Outcome(s)
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Endpoints :
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The number of newly presented lesions.
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Patient’s global assessment of disease activity scores based on a VAS scale
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of 1-10.
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The sum of the [diameter X severity] for each affected area.
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The disease activity index based on a calculated score.
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Secondary ID(s)
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2004-004555-19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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