An Open-label, Prospective, Observational, Single-blinded, Longitudinal, Cross-over Study to Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week on Thalamic Pathology in Subjects With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics
研究概览
简要总结
The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
详细描述
The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will exert similar, if not better effect on prevention of thalamic pathology, as compared to GA 20mg/daily. The secondary objective of this study is to investigate the effect of switching from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS patients diagnosed with MS according to the McDonald criteria
- •MS patients having a relapsing disease course
- •Being on GA monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care MRI at the time of switch to GA 40mg x 3/weekly
- •Having standard of care 3T MRI scan while on GA 20mg/daily treatment for at least 12-18 months prior to the start day of the of the GA 40mg x 3/weekly and at the time of switch to GA 40mg x 3/weekly Age over 18
- •Pass MRI health screening (in case of EGFR <59, the contrast will not be applied)
- •None of the exclusion criteria
排除标准
- •Patients who had a relapse within 30 days prior to MRI scan date
- •Patients who received steroid treatment within 30 days prior to the MRI scan date
- •Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
- •MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the 12 months prior to start of GA 40mg 3/weekly (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
结局指标
主要结局
Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics
时间窗: 1 year after enrollment
The primary endpoint is to explore the effect of GA 40mg x 3/weekly on thalamus pathology, as measured by changes in RD and AD on DTI TBSS in patients with RRMS, as compared to GA 20mg/daily.
次要结局
- Absolute and percent changes in normal-appearing white and grey matter as measured by fractional anisotropy and mean diffusivity using diffusion tensor imaging tract-based spatial statistics.(1 year after enrollment)
研究者
Robert Zivadinov, MD, PhD
Robert Zivadinov
University at Buffalo