NCT00134368已完成2 期
Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
详细描述
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)
次要结局
- Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
- Patient-Generated Global Assessment
- Skin texture assessment
研究者
研究点 (2)
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