Expired Study
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New Brunswick, New Jersey 08903


Purpose:

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


Study summary:

Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.


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) < 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.


NCT ID:

NCT00134368


Primary Contact:

Principal Investigator
Alice Gottlieb, MD, PhD
UMDNJ-RWJMS


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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