Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo
NCT ID: NCT00134368
Last Updated: 2008-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2003-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Etanercept
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Medicine and Dentistry of New Jersey
OTHER
Principal Investigators
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Alice Gottlieb, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMDNJ-RWJMS
Locations
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UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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4489
Identifier Type: -
Identifier Source: org_study_id