Chi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one
研究概览
简要总结
Chitinase 3-like 1 (Chi3L1) is a Human protein synthetized by inflammatory cells. Its serum level increases in case of autoimmune diseases, and especially during multiple sclerosis (MS). There is a need for biological markers predictive of treatment efficacy. MS outcomes one year from treatment initiation are predictive of long-term treatment efficacy. The hypothesis is that serum Chi3L1 level before treatment initiation could predict one year MS outcomes.
Primary objective: to show an association between the serum Chi3L1 level at diagnostic assessment and the clinical and radiological efficacy one year from initiation of the first disease modifying treatment (interferon beta, dimethyl fumarate or teriflunomide) in relapsing-onset multiple sclerosis (MS).
Secondary objectives: to determine the threshold value of the serum Chi3L1 level predicting the efficacy of treatment, and the added value of other potential biomarkers in cerebrospinal fluid collected at diagnostic assessment: Chi3L1, light chains of neurofilaments and interleukin 6.
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
- •Relapsing-onset multiple sclerosis according to the 2017 McDonald criteria
- •Blood and cerebrospinal fluid samples collected at diagnostic assessment from 2012 January 1st and kept in the Centre de Ressources Biologiques Lorrain
- •First platform disease modifying drugs : interferon-Beta, dimethyl fumarate or teriflunomide, introduced during the first 3 months after the diagnostic assessment
- •Disease modifying drugs maintained at least 3 months
- •Follow-up during at least 15 months after the first disease modifying drug initiation
- •At least one brain magnetic resonance imaging with gadolinium injection between months 3 and 15 after disease modifying drug initiation
排除标准
- •Objection to the use of personal data for research purpose
研究组 & 干预措施
Interferon-Beta
Patients with first treatment : interferon beta (1a subcutaneous 22 or 44 µg thrice a week OR 1a intramuscular 30 µg once a week OR 1b subcutaneous 250 µg every other day OR 1a PEGylated subcutaneous 125 µg every two weeks)
干预措施: Interferon-Beta (Drug)
结局指标
主要结局
Statistical association between the baseline chitinase 3-like 1 serum level and being "responder" at year one
时间窗: Baseline to month 15
Significant associations in each group of treatment Being "responder" means the presence of the four following : * No treatment withdrawal between months 3 and 15 after treatment initiation for reason of inefficacy * No relapse between months 3 and 15 * No increase of at least one point on the expanded disability status scale between months 3 and 15 * No gad-enhancing lesion on any magnetic resonance imaging scan between months 3 and 15 If any of these criteria is lacking, then the patient is considered as "non-responder".
次要结局
- Threshold chitinase 3-like 1 serum level at baseline to distinguish responders from non-responders(Baseline to month 15)
- Statistical association between the baseline chitinase 3-like 1 cerebrospinal fluid level and being "responder" at year one(Baseline to month 15)
- Statistical association between the baseline neurofilaments light chains cerebrospinal fluid level and being "responder" at year one(Baseline to month 15)
- Statistical association between the baseline interleukin 6 cerebrospinal fluid level and being "responder" at year one(Baseline to month 15)