Discoid Lupus Erythematosus (DLE) Clinical Trial
— DISCLUP2008Official title:
A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Florida Academic Dermatology Centers | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Florida Academic Dermatology Centers |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements | 20 weeks | Yes |