A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary aim of this study is to define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis (MS).
研究概览
简要总结
The primary aim of this study is to evaluate the effect of using Tysabri on changes in the brain using MRI and on disease progression in patients with relapsing-remitting Multiple Sclerosis over 5 years.
详细描述
This is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in natalizumab 1-year follow-up study
- •Participants were aged 18-65
- •Have clinically definite MS according to the Polman criteria of either RR or RSP disease type
- •EDSS scores ≤6.5
- •disease duration <30 years
- •normal kidney function (creatinine clearance >59 mL/min)
- •started therapy either with natalizumab or IM interferon beta-1a (IFNβ-1a)
- •Signed informed consent
- •Normal kidney functioning (creatinine clearance >59)
- •None of the exclusion criteria
排除标准
- •A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to 5-year follow-up visit
- •Nursing mothers or pregnant women who will need to undergo 5-year follow-up MRI
- •Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
- •Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
结局指标
主要结局
The primary aim of this study is to define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis (MS).
时间窗: 5 years
Evaluation of MRI images from baseline in comparison with a 5 year MRI.
次要结局
- The secondary objective of this study is to define the effect of the number of natalizumab cycles on accumulation of T2-LV and T1-LV and their VW-MTR changes over 5 years.(5 years)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo