Study of Biomarkers of the Response to Biotine (BIOMARBIOT)
Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).
Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo.
The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.
The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Dijon、法国、21079
- CHU Dijon Bourgogne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 to 65 years old
- inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database
- Patients with health insurance cover
- Patients who have provided written informed consent (OFSEP)
Exclusion Criteria:
- Patients unable to understand the information sheet
- Patients with remittent or active progressive MS
- Patients with a change in the disease-modifying treatment within the previous 3 months
- Patients treated with corticosteroids in the month before inclusion
- Impossibility to provide patients with the necessary information
- Patients in custody
- Patients under guardianship
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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validated disability scale (EDSS)
大体时间：change from baseline validated disability scale at 3 and 12 months
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change from baseline validated disability scale at 3 and 12 months
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Walking test
大体时间：change from baseline walking test at 3 and 12 months
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change from baseline walking test at 3 and 12 months
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Evolution of blood lipid biomarkers
大体时间：change from baseline evolution of biomarkers at 3 and 12 months
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change from baseline evolution of biomarkers at 3 and 12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MOREAU MedDay 2016
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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