Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)? A Longitudinal Study Using Whole Brain, Neocortical and Subcortical Atrophy Rates and Patient Reported Outcomes (PROs).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in Brain Atrophy Rate
研究概览
简要总结
Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period.
Primary hypothesis:
The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true "disease activity free" state).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •18-55 inclusive years of age at the time of informed consent
- •Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria
- •Currently taking Tysabri
排除标准
- •Systemic steroid users
- •comorbidities that could confound MRI outcomes
结局指标
主要结局
Change in Brain Atrophy Rate
时间窗: Baseline, Year 1, and Year 2
次要结局
- Change in Mean Cortical Thickness(Baseline, Year 1, and Year 2)
- Change in Neocortical Gray Matter Volume(Baseline, Year 1, and Year 2)
- Change in Subcortical Gray Matter Volume(Baseline, Year 1, and Year 2)