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
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