Etanercept in Hidradenitis Suppurativa

NCT00329823 | Completed Phase 2

• 1 other identifier: 2004-004555-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa, etanercept

Outcome Measures

Primary Outcomes (6)

• 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.

Interventions

Etanercept sc 50mg per week for 12 weeks DRUG

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitive diagnosis of hidradenitis suppurativa
• Age \> 16 years
• No presence of infections other then hidradenitis suppurativa.
• Disease activity index \> 20
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

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

Athens, 124 64, Greece

Location

Related Publications (1)

• 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.

  PMID: 16536817 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  4th Department of Internal Medicine, University of Athens, Greece

  STUDY DIRECTOR

• Helen Giamarellou, MD, PhD

  4th Department of Internal Medicine, University of Athens, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: September 1, 2005
• Study Completion: May 1, 2006
• Last Updated: May 25, 2006

Record last verified: 2006-05

Locations

GR (1)