Status:
UNKNOWN
The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus
Lead Sponsor:
Florida Academic Dermatology Centers
Conditions:
Discoid Lupus Erythematosus (DLE)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
Eligibility Criteria
Inclusion
- Subjects with discoid lupus erythematosus .Subjects require to have confirmation of diagnosis by a skin biopsy .This can be undertaken at the screening visit if no previous biopsy confirmation available.
- And;
- Having failed steroids (topical, intralesional, systemic) and are candidates for antimalarial therapy
- Negative ANA
- Have no history of latent or active TB prior to screening.
Exclusion
- Subjects allergic to sunscreens
- Prior treatment with anti-TNF therapies
- Subjects who do not have a previous skin biopsy result confirming a DLE diagnosis and who are unwilling to undergo this procedure at screening.
- Subjects currently receiving systemic steroid therapy (or have received in the last 3 months)
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Prior or concurrent use of cyclophosphamide therapy
- Concurrent sulfasalazine therapy.
- Known HIV-positive status or known history of any other immuno-suppressing disease.
- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication
- Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP \<80 mm Hg or \> 160 or diastolic BP \> 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years \[other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer\])
- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00797784
Start Date
October 1 2008
End Date
April 1 2011
Last Update
May 26 2010
Active Locations (1)
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1
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136