Patient Research Cohort: Rapidly Evolving Multiple Sclerosis Opening the Window of Therapeutic Opportunity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy.
研究概览
简要总结
The primary goal of the research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions, or access to second- line treatments.
Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping and immunological analysis of blood samples, aiming to identify and validate biomarkers of disease activity and response to treatment and prognostic markers.
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
- 未提供
排除标准
- •Contraindication to MRI including but not limited to intracranial aneurism clips (except Sugita), history of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray), pacemaker and non-MR compatible heart valves, inner ear implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1.5 hours in the MRI scanner.
- •If female, positive urine pregnancy test
- •History or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min)
- •Inability to give informed consent/comply with study procedures
结局指标
主要结局
Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy.
时间窗: Two years
The primary goal of the observational research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions or appropriate management for rapidly evolving multiple sclerosis (MS). This was devised as a single, combined primary outcome measure. The primary outcome is the proportion of research cohort subjects either referred into a clinical trial or offered treatment with an appropriate second-line therapy. (approved Protocol Version 4.1 - September 13th, 2011). The statistical assumption based on data from similar research cohorts stipulated that 50% of recruited patients will consent to proceed to further clinical trials or access new therapies.
次要结局
- Development of Biomarkers(two years)
- Development of Clinical Prognostic Markers.(two years)
- Access and Utilization of Cohort Data(two years)