Silent Progression Monitoring in Extreme Phenotypes. SP-MS, Despite an Effective Early Highly Active Treatment as a Paradigm SPAM Study (Silent Progression Activity Monitoring)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,230
- 试验地点
- 1
- 主要终点
- Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
研究概览
简要总结
Real-World Data (RWD) exploring the natural history of MS suggested that relapses do not significantly influence the progression of irreversible disability. Disability progression independent of relapses activity (PIRA) has been confirmed as a frequent relapsing-remitting multiple sclerosis (RRMS) phenomenon based on Randomized Clinical Trials (RCT). Recently, RWD demonstrated that the absence of markers of inflammation (No Evidence of Disease Activity (NEDA) at 2 years did not predict long-term stability. Silent progression has been proposed to describe the insidious disability that accrues many patients who satisfy traditional criteria for relapsing-remitting MS. In this study, the investigators would like to evaluate the occurrence of the SPMS in a population of RRMS patient with an Highly Active Treatment (HAT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
时间窗: Baseline: beginning of highly active treatment
DMT administered since MS onset: number of DMT and type
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
时间窗: Baseline: beginning of highly active treatment
At least 1 gadolinium enhancement T1 lesion on MRI
次要结局
- To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.(Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).)
- To determine re-baseline clinical and MRI markers associated with SPMS diagnosis despite an early, practical, HAT.(Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).)
- Detremination of the impact of different definition of SPMS according to the clinician(Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).)
- Dertermination of the impact of different definition of SPMS according to Lublin.(at 5 years)
- To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS(at 5 years)
- To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.(Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).)
- Analyze of the influence of NEDA (No Evidence of Disease activity)(at baseline and at 5 years)
- Analyze of the influence of MEDA (Mild Evidence of Disease Activity)(at baseline and at 5 years)
- Dertermination of the impact of different definition of SPMS according to Lorscheider.(at 5 years)