The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus

Study Overview
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Brief Summary
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A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus

Official Title
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A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus

Conditions
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Discoid Lupus Erythematosus (DLE)

Intervention / Treatment
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* Drug: etanercept(Enbrel®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etanercept(Enbrel®)|etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline. |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements |  | 20 weeks |