NCT01695434已完成不适用
A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months
适应症
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
- To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
研究概览
简要总结
To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
详细描述
This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
- •Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
- •Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
- •Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
- •MS patients having a RR disease course (Lublin and Reingold, 1996)
- •Age 18-65 (healthy controls will be matched to MS patients for age and sex)
- •Signed informed consent at the 24-month follow-up
- •Pass MRI health screening
- •MS patients passing contrast screening
- •MS patients having normal kidney function (creatinine clearance >59)
- •None of the exclusion criteria
排除标准
- •Patients who had a relapse within 30 days prior to MRI baseline scan date
- •Patients who received steroid treatment within 30 days prior to the MRI baseline 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 follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
- •MS patients having abnormal kidney function (creatinine clearance <59)
结局指标
主要结局
To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.
时间窗: 24 months
MRI collected from RRMS patients who have taken Copaxone for 24 months
次要结局
- To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months.(24 months)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo
研究点 (1)
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