Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- LM CE lesions at 24 months
研究概览
简要总结
This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Diagnosed with MS according to McDonald criteria
- •Age 18-65 years
- •Relapsing disease course
- •Expanded Disability Status Scale (EDSS) score of ≤ 5.5
- •MRI obtained at baseline (medication start date), 12 months, and 24 months
- •Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label
- •Clinical information available over the 24 month follow-up
- •None of the exclusion criteria
排除标准
- •Diagnosis of non-relapsing MS
- •Use of experimental drug or investigational procedure during the study period
- •Pregnancy during study period
- •Severe hepatic impairment
- •Relapse within 30 days prior to any of the 3 MRIs
- •Corticosteroid use within 30 days prior to the MRIs
- •Teriflunomide patients who have used leflunomide
- •Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone
- •Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation
研究组 & 干预措施
Aubagio
Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
干预措施: Teriflunomide (Drug)
Tecfidera
Individuals diagnosed with multiple sclerosis (MS) who have been treated with dimethyl fumarate (Tecfidera) and matched with the teriflunomide (Aubagio) patients on age, sex, disease duration, and disability level
干预措施: Dimethyl Fumarate (Drug)
结局指标
主要结局
LM CE lesions at 24 months
时间窗: 24 months
Frequency of leptomeningeal (LM) lesions as measured by presence (number) of LM contrast enhancing (CE) lesions foci on three-dimensional fluid-attenuated-inversion recovery (3D_FLAIR) MRI performed 10 minutes post-contrast injection between those on teriflunomide and dimethyl fumarate
Percent change in CGM between teriflunomide and dimethyl fumarate
时间窗: 24 months
Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate
CGM atrophy and LM inflammation
时间窗: 24 months
Association between the development of CGM atrophy and LM inflammation
次要结局
未报告次要终点
研究者
Robert Zivadinov, MD, PhD
Director, Principal Investigator
University at Buffalo