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

Phase 2

• Conditions: Discoid Lupus Erythematosus (DLE)

• Registration Number: NCT00797784
• Lead Sponsor: Florida Academic Dermatology Centers

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Status Verified: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements	20 weeks

Trial Locations

Locations (1)

Florida Academic Dermatology Centers; 🇺🇸 Miami, Florida, United States