DRKS00030403招募中不适用
An observational, non-interventional, multicenter, prospective study to explore the association of MS-related disability worsening and loss of thalamus volume - PENTAGO
jung diagnostics GmbH0 个研究点目标入组 600 人开始时间: 2022年10月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •? MS, as diagnosed by the revised 2017 McDonald criteria
- •? Exhibiting a relapsing clinical course and history of brain MRI lesions consistent with MS
- •? Ages 18 to 55 years, inclusive
- •? Meet one of the following disease activity criteria
- •a. more than 10 T2 lesions at the time of the first visit OR
- •b. at least one documented relapse with the last 12 months prior to the first visit OR
- •c. documented evidence of at least 1 Gd-enhancing lesion on brain MRI within the last 12 months prior to the first visit OR
- •d. documented evidence of at least one new or one enlarging T2 lesion within the last 12 months prior to the first visit.
- •? Either receive or about to receive oral immune therapies as first or second DMT approach, such as teriflunomide, ozanimod, dimethylfumarate, ponesimod, and diroximethylfumarate.
- •? Either receive or about to receive second line therapies, such as e.g. monoclonal antibodies, but the number of patients receiving monoclonal antibodies should be restricted to 1/3 of the overall study population.
排除标准
- •? Primary or secondary progressive MS at time of enrollment
- •? Patients who are not eligible to receive MRI
研究者
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