NCT01284322已完成1 期
OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To investigate the effect of fresolimumab on TGF-beta responsive gene expression in skin after treatment with fresolimumab compared to pre-treatment TGF-beta responsive gene expression.
研究概览
简要总结
The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.
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
- •Meet ACR criteria for diffuse systemic sclerosis
- •< 24 months since onset of first SSc manifestation other than Raynaud's phenomenon
- •Modified Rodnan Skin Score ≥ 15
- •Male or female adult ( ≥ 18 years of age)
- •Able and willing to give written informed consent and comply with study protocol
排除标准
- •Moderate or severe pulmonary disease w/ FVC < 80% or DLCO < 70% or ground glass and fibrosis > 20% of lung fields by HRCT
- •Treatment with investigational drug within 4 weeks of screening
- •Ongoing use of high dose steroids (> 10mg/day) or unstable steroid dose in past 4 weeks
- •Treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening
- •Positive for HIV, HBV, and/or HCV
- •Known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening
- •Patients w/ history of malignancy or premalignant lesion
- •History of keratoacanthoma or squamous cell carcinoma
- •Moderate to severe hepatic impairment
- •SSc renal crisis within 6 months or creatinine > 2.0
- •Lack of IV access for medication administration
- •Moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina
- •Anemia (Hb < 8.5 gm/dL)
- •Thrombocytopenia or blood clotting disorder
- •Patients with organ transplant (including allogeneic bone marrow transplant)
研究组 & 干预措施
Fresolimumab
Experimental
干预措施: Fresolimumab (Drug)
结局指标
主要结局
To investigate the effect of fresolimumab on TGF-beta responsive gene expression in skin after treatment with fresolimumab compared to pre-treatment TGF-beta responsive gene expression.
时间窗: 7 weeks
TGF-beta regulated skin gene expression
To evaluate safety of fresolimumab in patients with scleroderma
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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