NCT06737419已完成不适用
Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Number of Patients Categorized by Number of Relapses
研究概览
简要总结
This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（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
- 未提供
结局指标
主要结局
Number of Patients Categorized by Number of Relapses
时间窗: Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
时间窗: From Baseline up to Month 6 and Month 12
次要结局
- Age(Baseline)
- Number of Patients per Demographic Category(Baseline)
- Mean Duration of Disease(Baseline)
- Number of Patients by Most Recent Disease Course(Baseline)
- Number of Patients by Patient Determined Disease Steps (PDDS) Score(Baseline, Month 6, Month 12)
- Number of Patients Categorized by Comorbidity(Baseline)
- Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)(Baseline)
- Number of Prior DMTs(Baseline)
- Number of Patients who Switched From a DMT to OMB(Baseline)
- Duration of Time Between Prior DMT and Initiating OMB Treatment(Baseline)
- Number of Patients by Most Recent Prior DMT(Baseline)
- Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation(Baseline)
- Number of Patients by Number of New Brain T2 Lesions(Baseline, Month 6, Month 12)
- Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions(Baseline, Month 6, Month 12)
- Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
- Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
- Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
- Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
- Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
- Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment(From Baseline up to Month 6 and Month 12)
- Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment(Month 6 and Month 12)
- Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment(Month 6 and Month 12)
研究者
研究点 (1)
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