NCT01881191已完成不适用
Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.
研究概览
简要总结
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
详细描述
Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.
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
- •Subjects aged 18-65
- •Clinically definite MS according to the Polman criteria, 52
- •Relapsing MS or Healthy Control (no neurological disorders)
- •Expanded Disability Status Scale (EDSS) scores ≤5.5
- •Disease duration <30 years
- •Normal kidney function (creatinine clearance >59 mL/min) (patients only)
- •Signed informed consent
- •None of the exclusion criteria
排除标准
- •MS patients with hepatic impairment
- •Nursing mothers or pregnant women who will need to undergo 12 months follow-up
- •Women of childbearing potential not using reliable contraception
- •Patients currently treated with leflunomide
- •Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
- •A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
- •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
- •Other pathology related to MRI abnormalities
结局指标
主要结局
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.
时间窗: baseline, 6 month and 12 month
次要结局
- The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.(baseline, month 6 and month 12)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo
研究点 (1)
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