NCT00949546已完成不适用
Treatment of Hidradenitis Suppirativa With Etanercept Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physician global assessment of HS of clear or mild at week 12
研究概览
简要总结
Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic HS for > 6months defined as tender and/or painful, red nodules and/or plaques (confluent nodules) with or without scarring, foul odor, or draining sinuses clinically with HS
- •Localizes to skin folds including any of axillx, breast, abdomen and groin
- •active disease
- •Negative pregnancy test within 7 days before the first dose of study drug
- •Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
排除标准
- •Concurrent active infection including tuberculosis
- •Concurrent therapy or therapy 30 days prior with systemic corticosteroids, systemic immunosuppressants, systemic retinoids or ant-TNF agents
- •Severe comorbidities (diabetes mellitus requiring insulin, Q F of any severity, MI, unstable angina eectoris, uncontrolled hypertension, oxygendependent severe pulmonary disease, history of cancer *thin 5_ years except cutaneous basal cell or squamous cell carcinoma or in situ cervical carcinoma, history of TB or TB exposure, chronic hepatitis B or C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
- •Currently enrolled or enrolled within 90 days prior in any trial for treatment of HS
- •Known HIV positive
- •Contraindication to etanercept as defined in package insert
研究组 & 干预措施
placebo controlled
A randomized, double-blind trial of 3 months duration comparing etanercept 50 mg sc twice weekly to placebo in 20 patients with HS. Patients will be randomized with equal allocation to the two treatment groups.
干预措施: etanercept (Drug)
结局指标
主要结局
Physician global assessment of HS of clear or mild at week 12
时间窗: Week 12
次要结局
未报告次要终点
研究者
研究点 (1)
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