NCT01740180终止不适用
Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
Centre Hospitalier Universitaire de Nīmes11 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 11
- 主要终点
- Presence/absence of cortico-sparing treatments
研究概览
简要总结
The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.
详细描述
This is an observational study. Data will be prospectively collected, starting with a detailed baseline description of disease and treatment status, followed by updates everything six months for the next three years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient correctly informed about the study
- •Symptoms and/or clinical signs indicating that the brain stem is affected
- •MRI shows punctate gadolinium highlights and/or curvilinear bridge and/or middle cerebellar peduncles
- •Clinical and radiological cortico sensitivity
- •If a cerebral biopsy has been performed, presence of a lymphocytic, histiocytic or lympho-hysticytic infiltrate
排除标准
- •symptoms and/or clinical signs indicating impairment other than the central nervous system
- •Cortical impairment present on MRI, microbleeds, stenosis on magnetic resonance angiography, or pacchymeningitis
- •Presence of other diseases that could explain such clinical and radiological signs (see inclusion criteria)
- •If a cerebral biopsy has been performed, presence of signs of malignancy (eg, clonal proliferation, cellular atypia), vasculitis, granuloma, or demyelination
结局指标
主要结局
Presence/absence of cortico-sparing treatments
时间窗: baseline to 3 years
次要结局
- Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids(36 months)
- CLIPPERS relapse severity(36 months)
- Presence/absence of vascular risk factors(36 months)
- Presence/absence of allergies(36 months)
- Complete description of all treatments being taken(36 months)
- Weight (kg)(36 months)
- Relapse-free interval rhythm(36 months)
研究者
研究点 (11)
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