Assessment of COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab in the United States: A Multicenter Medical Record Review Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)
研究概览
简要总结
This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.
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 Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Prior Disease Modifying Therapy (DMT)
时间窗: From 2 weeks up to 6 months post-vaccine
DMTs included: DMT naïve, prior anti-CD20/sphingosine 1-phosphate (S1P) and prior non-anti-CD20/S1P.
Number of Ofatumumab-treated Patients with an Immune Response to FDA-authorized COVID-19 Vaccination by Vaccination Status
时间窗: From 2 weeks up to 6 months post-vaccine
Three vaccination status levels were defined. Patients who were receiving ofatumumab at the time of: 1. full COVID-19 vaccination and who received a booster vaccination (while continuing to receive ofatumumab), or 2. booster vaccination but were not receiving ofatumumab at the time of full COVID-19 vaccination, or 3. full COVID-19 vaccination but did not receive a booster vaccination or had discontinued ofatumumab before receipt of a booster vaccination. Full COVID-19 vaccination was defined as two doses of messenger ribonucleic acid (mRNA) vaccines (i.e., Pfizer, Moderna) or one dose of a single-dose adenoviral vaccine (i.e., Johnson and Johnson).
次要结局
- Mean Age at Index Date by Vaccination Status(Index date)
- Mean Age at Index Date by Prior Disease Modifying Therapy (DMT)(Index date)
- Gender at Index Date by Vaccination Status(Index date)
- Gender at Index Date by Prior DMT(Index date)
- Race at Index Date by Vaccination Status(Index date)
- Race at Index Date by Prior DMT(Index date)
- Number of Patients per United States Region at Index Date by Vaccination Status(Index date)
- Number of Patients per United States Region at Index Date by Prior DMT(Index date)
- Time since MS Diagnosis at Index Date by Vaccination Status(Index date)
- Time since MS Diagnosis at Index Date by Prior DMT(Index date)
- Number of Patients with Relapsing-remitting Multiple Sclerosis (MS) at Index Date by Vaccination Status(Index date)
- Number of Patients with Relapsing-remitting MS at Index Date by Prior DMT(Index date)
- Number of Patients with Secondary Progressive MS at Index Date by Vaccination Status(Index date)
- Number of Patients with Secondary Progressive MS at Index Date by Prior DMT(Index date)
- Number of Patients with Primary Progressive MS at Index Date by Vaccination Status(Index date)
- Number of Patients with Primary Progressive MS at Index Date by Prior DMT(Index date)
- Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Prior DMT(Within 12 months preceding index date)
- Mean Number of Comorbidities Within 12 Months Preceding Index Date by Vaccination Status(Within 12 months preceding index date)
- Mean Number of Comorbidities Within 12 Months Preceding Index Date by Prior DMT(Within 12 months preceding index date)
- Number of Patients by Most Common Comorbidities (greater than 15%) Within 12 Months Preceding Index Date by Vaccination Status(Within 12 months preceding index date)
- Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation by Vaccination Status(Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination))
- Number of Patients Treated with DMTs any Time Prior to Ofatumumab Initiation Categorized by Prior DMT(Within 3 years of index date (defined as date of completion of full COVID-19 vaccination or date of booster vaccination))