The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus
Status unconfirmed · Phase 2
Conditions studied: Discoid Lupus Erythematosus (DLE)
In brief
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
Key facts
- Study ID
- NCT00797784
- Run by
- Florida Academic Dermatology Centers
- People needed
- 20
- Starts
- 2008-10-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2010-05-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Florida Academic Dermatology Centers — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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