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

NCT ID: NCT00797784

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-04-30

Brief Summary

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

Conditions

Discoid Lupus Erythematosus (DLE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

etanercept(Enbrel®)

etanercept(Enbrel®) 50mgs subcutaneous (SC) injections twice weekly for 20 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida Academic Dermatology Centers

OTHER

Sponsor Role: lead

Responsible Party

Florida Academic Dermatology Centers

Locations

Florida Academic Dermatology Centers

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Annika M Grant, RN, MBA

Role: CONTACT

annika@fadcenter.com

305 324 2110 ext. 210

Facility Contacts

Annika M Grant, RN,MBA

Role: primary

annika@fadcenter.com

305-324-2110 ext. 210

Other Identifiers

FADC

Identifier Type: -

Identifier Source: org_study_id