Clinical trial NCT00797784: The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus
Official title: A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Discoid Lupus Erythematosus (DLE)
Lead sponsor: Florida Academic Dermatology Centers
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 20 weeks
Secondary outcomes:
measure: Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
Study officials:
References: