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

Information source: Florida Academic Dermatology Centers
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Discoid Lupus Erythematosus (DLE)

Intervention: etanercept(Enbrel®) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Florida Academic Dermatology Centers

Overall contact:
Annika M Grant, RN, MBA, Phone: 305 324 2110, Ext: 210, Email: annika@fadcenter.com

Summary

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

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Annika M Grant, RN, MBA, Phone: 305 324 2110, Ext: 210, Email: annika@fadcenter.com

Florida Academic Dermatology Centers, Miami, Florida 33136, United States; Recruiting
Annika M Grant, RN,MBA, Phone: 305-324-2110, Ext: 210, Email: annika@fadcenter.com
Francisco A Kerdel, M.D., Principal Investigator
Additional Information

Starting date: October 2008
Last updated: May 25, 2010

Page last updated: February 07, 2013

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