ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Steroid toxicity
研究概览
简要总结
An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.
详细描述
This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.
After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks.
At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
- •Patient on >5 mg prednisone for pulmonary indications
- •FVC <85% predicted
- •Prednisone dose not reduced in prior 3 months
- •Deterioration of pulmonary disease over the past year
- •Decrease in FVC >5%
- •Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).
排除标准
- •adrenal insufficiency (Addison's disease)
- •Scleroderma
- •a fungal infection
- •herpes infection of the eyes
- •osteoporosis
- •a stomach ulcer
- •congestive heart failure
- •high blood pressure
- •recent surgery
- •if you are allergic to pork proteins
- •Do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin.
- •Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab) in prior six months
- •Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
- •Patients requiring therapy for pulmonary hypertension
- •Females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening.
- •Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days)
- •Any other condition that the investigator feels would pose a significant hazard to the patient if Acthar Gel therapy is initiated.
研究组 & 干预措施
80 units
80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading
干预措施: Acthar gel (Drug)
40 units
40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
干预措施: Acthar gel (Drug)
结局指标
主要结局
Steroid toxicity
时间窗: 24 weeks
Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
次要结局
- Chest x-ray(24 weeks)
- Forced Vital Capacity (FVC)(24 weeks)
- PET scan(24 weeks)
- Sarcoidosis Health Questionnaire(24 weeks)
研究者
Robert P Baughman
Professor
University of Cincinnati