Use of CXCL9 as a Biomarker of Acthar Efficacy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Decrease in blood CXCL9 levels by 50%
研究概览
简要总结
The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).
详细描述
The investigators will test whether Acthar gel's anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.
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
- 否
入选标准
- •Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement
- •Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate
排除标准
- •Chronic infections (e.g. tuberculosis, viral, fungal, bacterial)
- •Inflammatory conditions
- •Coexisting lung disease
- •Congestive heart failure
- •Uncontrolled hypertension
- •Recent surgery
- •Active peptic ulcers
- •Osteoporosis
研究组 & 干预措施
Acthar gel
After a 4-week period of baseline monitoring, Acthar gel will be administered by intramuscular or subcutaneous injection. Initial dosing will be 40 U every 72 hours (or twice per week) for 4 weeks. Dosage will then be increased to 80 U with similar frequency for 8 weeks and up to 16 weeks.
干预措施: Acthar gel (Drug)
结局指标
主要结局
Decrease in blood CXCL9 levels by 50%
时间窗: within 6 months
次要结局
- Improvement in FVC by 5% of predicted(within 6 months)
- Improvement in dyspnea score(within 6 months)