A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- 50% Reduction in Physician's Global Assessment Score (Percent of Participants)
研究概览
简要总结
This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a dose of 50 mg per week in patients with psoriasis.
The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis. Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life.
The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF- α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in the signs and symptoms of hidradenitis.
This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up. Approximately 21 subjects will participate at the University of Pennsylvania.
Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years.
详细描述
Purpose: The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa. The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life.
Duration:
Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years.
Subject Recruitment and Selection:
It is planned that enrollment will be 12-21 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be able to give informed consent.
- •Severe hidradenitis suppurativa clinically confirmed by the investigator and defined as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus track and scar formation (e.g. Stage II or III disease) that has not responded to previous standard therapies such as topical or oral antibiotics, or intralesional injections of steroids.
- •Age 18 or older.
- •Willingness to use at least one form of effective contraception during the study period and for one month after discontinuation of etanercept if female and of child bearing capacity or if male. If the patient elects to use a hormonal form of contraception then the patient must be on the same form of hormonal contraception for 90 days prior to the start of Etanercept and must plan to continue using the same form of hormonal contraception for the duration of the study (e.g. until week 18).
排除标准
- •Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30 days prior to day 0 or at any time during the study treatment period.
- •Use of systemic immunosuppressants within 90 days prior to day 0 of this study.
- •Use of an investigational medication 90 days prior to day 0 of this study.
- •Use of a live vaccine 90 days prior to day 0 of this study.
- •Any previous use of TNF- α inhibitors.
- •If using a hormonal form of contraception, the patient will be excluded if they have not used the same form of hormonal contraception for 90 days prior to the start of the etanercept (e.g. day 0) or are not willing to continue the use of the same form of hormonal contraception for the duration of the study.
- •Active infection within 30 days of day 0 of the study that is moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating with inability to work or perform normal daily activities) or requires treatment with antibiotics.
- •History of tuberculosis or other mycobacterial disease or positive screening visit purified protein derivative (PPD) (≥ 5 mm).
- •Known history of an immuno-suppressing disease (e.g. HIV)
- •Clinically significant abnormality in liver function, renal function, chemistry panel or complete blood count (CBC) (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 2.0 mg/dL) or severe co-morbidities defined as diabetes mellitus requiring insulin, congestive heart failure, history of myocardial infarction, unstable angina, uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure >110 mmHg), severe pulmonary disease (requiring oxygen therapy), history of cancer within 5 years (other than resected basal cell or squamous cell carcinoma and in situ cervical cancer), known history of active hepatitis B or C or HIV infection, history of demyelinating diseases or lupus.
- •Pregnancy or lactation
- •History of alcohol or drug abuse within 12 months of screening visit
研究组 & 干预措施
Treatment arm
Open-label treatment with etanercept 50 mg/week subcutaneous injection
干预措施: etanercept (Drug)
结局指标
主要结局
50% Reduction in Physician's Global Assessment Score (Percent of Participants)
时间窗: 12 weeks
Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks. PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.
次要结局
- 50% Reduction in Number of Lesions (Percent of Participants)(12 weeks)
- Patient Global Assessment(12 weeks)
- Patient's Pain Score(12 weeks)
- Dermatology Life Quality Index Score (DLQI)(12 weeks)
研究者
Joel Gelfand
Professor, Dermatology Department
University of Pennsylvania