NCT00797784Unknown2 期
A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus
Florida Academic Dermatology Centers2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline.
研究概览
简要总结
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with discoid lupus erythematosus .Subjects require to have confirmation of diagnosis by a skin biopsy .This can be undertaken at the screening visit if no previous biopsy confirmation available.
- •Having failed steroids (topical, intralesional, systemic) and are candidates for antimalarial therapy
- •Negative ANA
- •Have no history of latent or active TB prior to screening.
排除标准
- •Subjects allergic to sunscreens
- •Prior treatment with anti-TNF therapies
- •Subjects who do not have a previous skin biopsy result confirming a DLE diagnosis and who are unwilling to undergo this procedure at screening.
- •Subjects currently receiving systemic steroid therapy (or have received in the last 3 months)
- •Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- •Prior or concurrent use of cyclophosphamide therapy
- •Concurrent sulfasalazine therapy.
- •Known HIV-positive status or known history of any other immuno-suppressing disease.
- •Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication
- •Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- •Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])
- •Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
结局指标
主要结局
Proportion of patients responding to study treatment using the Cutaneous Lupus Erythematous Disease Area Severity Index(CLASI)defined as a decrease of 50% form baseline.
时间窗: 20 weeks
次要结局
- Change from baseline to week 20 in Dermatology Life Quality Index and Pysician's Global Assessment of disease measurements(20 weeks)
研究者
研究点 (2)
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