Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo

Exclusion Criteria

• •Unable to consent
• •History of non-compliance with other therapies
• •Concurrent therapy for vitiligo
• •Systemic or photo-therapy within 4 weeks
• •Topical therapy within 2 weeks
• •Any medical condition in which etanercept would be contraindicated
• •Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
• •Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study.
• •Lactation
• •History of alcohol or drug abuse one year before and during the study.
• •Any participation in another investigational drug study during the 4 weeks preceding this study.
• •Known HIV-positive status; known history of any other mycobacterial disease or any other immuno-suppressing disease.
• •Presence of a grade 3 or 4 infection \< 30 days prior to the screening visit; between the screening visit and the first day of treatment on study; or any time during the study that, in the opinion of the Investigator, would preclude participation in the study.
• •Patients should not receive live vaccines for 3 months prior to, or while on, study.
• •A prior history of tuberculosis, and/or a positive PPD skin test and positive CXR at screening.
• •Patients with previous or current exposure to any of the following TNF antagonists:
• •* etanercept (Enbrel);
• •* adalimumab (Humira); or
• •* infliximab (Remicade).
• •These patients will not be eligible, even with a wash-out. Patients with previous or current exposure to Kineret will NOT be eligible, even with a wash-out. However, patients with prior or current exposure to biologics directed against T-cells (e.g. alefacept, efalizumab, siplizumab, etc.) will be eligible for enrollment into the study after a wash-out period of 4 weeks before first dose of study drug (baseline visit). It has to be protocol specific also.
• •The subject has, in the Investigator's opinion, a chronic, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular (congestive heart failure \[CHF\] of any severity; myocardial infarction \[MI\], cerebrovascular accident \[CVA\] or transient ischemic attack \[TIA\] within 3 months of screening visit; unstable angina pectoris; uncontrolled hypertension \[sitting systolic blood pressure (BP) \< 80 mm Hg or \> 160 or diastolic BP \> 100 mm Hg\]), or neurological disease; known systemic lupus erythematosus (SLE); diabetes; or any other concomitant medical condition that places the participant at risk by participating this study and/or that may interfere with the conduct of the study.
• •Chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy.