Discoid Lupus Erythematosus (DLE)
Conditions
Brief summary
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
Interventions
DRUGetanercept(Enbrel®)
etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks
Sponsors
Florida Academic Dermatology Centers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements | 20 weeks |
Countries
United States
Contacts
Primary ContactAnnika M Grant, RN, MBA
Outcome results
None listed