NCT03250169终止不适用
Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Blood and CSF neurofilaments in Alemtuzumab patients over 24months
研究概览
简要总结
Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.
详细描述
Primary
- To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.
Secondary 2. To assess prognosis at the end of the study based on neurofilament status. 3. To correlate neurofilament levels with clinical and MRI markers of disease activity. 4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
- •Age 18-55 years.
- •EDSS score between 0-5.
- •Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D
排除标准
- •A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
- •Those unable to comply with study requirement
结局指标
主要结局
Blood and CSF neurofilaments in Alemtuzumab patients over 24months
时间窗: 2 years
Neurofilaments
次要结局
- Overall clinical response based on neurofilament response(2 years)
- Longitudinal assessment of other biomarkers of inflammation & plasticity(2 years)
- Neurofilament status and association with clinical and MRI markers of disease activity.(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Neurofilament Assay for the Diagnosis of ALSProgressive Motor Neuron Disease Without Definite DiagnosisNCT05077696Assistance Publique - Hôpitaux de Paris100
进行中（未招募）
不适用
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS PatientsMultiple SclerosisNCT04860947Centre Hospitalier Universitaire de Nīmes200
Enrolling By Invitation
不适用
Neurofilament Light Chain as Diagnostic and Prognostic Marker in naïve Multiple Sclerosis PatientsRole of Neurofilment in Diagnosis of Multiple SclerosisNCT06197841Assiut University85
尚未招募
不适用
Biomarkers in ConcussionConcussion, MildConcussion, IntermediateConcussion, SevereNCT05943561Medstar Health Research Institute100
招募中
不适用
Serial Serum Neurofilament measurements for the diagnosis and prediction of chemotherapy-induced polyneuropathyG62.0Drug-induced polyneuropathyDRKS00027898Charité Universitätsmedizin BerlinKlinik für Neurologie70