The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus (DISCLUP2008)

Florida Academic Dermatology Centers

Status and phase

Unknown

Phase 2

Conditions

Discoid Lupus Erythematosus (DLE)

Treatments

Drug: etanercept(Enbrel®)

Study type

Interventional

Funder types

Other

Identifiers

FADC

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.