study of the efficacy and safety of etanercept in adults with vitiligo

Conditions: Vitiligo

Summary: the purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.

subjects will self-administer etanercept 50 mg sq twice weekly for 6 months. lesion repigmentation will be evaluated at monthly visits.

Eligibility criteria:
inclusion criteria: * vitiligo patients aged 18 years and older * vitiligo patients with evaluable lesions; duration of 3 months to 10 years. * disease interferes significantly with quality of life and/or involving 3% or more body surface area * subjects must have a negative tuberculin (tb) skin test at entry into the study * if subject is a female of childbearing potential, she must agree to use adequate contraception (adequate contraception can include abstinence) and must have a negative serum pregnancy test the day of administration of study medication. * if subject is a male and has reached puberty, he must agree to use adequate contraception during the study and for 1 month after discontinuation from study. * subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections * subject must be able to give informed consent; must authorize release and use of protected health information; and, if applicable, must assent to participate prior to enrollment to this study. 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 \[sitting systolic blood pressure (bp) \ 160 or diastolic bp \> 100 mm hg\]), 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.

Keywords: vitiligo etanercept