NCT04650321招募中4 期
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Severe infusion reactions
研究概览
简要总结
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
详细描述
The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current active patient of Rocky Mountain MS Center at the time of final study consent.
- •Between 18-55 years of age at the time of final study consent.
- •Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19
- •Has at minimum completed their first 600 mg dose of ocrelizumab.
- •Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent.
- •Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20
- •Can complete patient reported outcomes developed and validated as English written scales.
- •Must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and FDA regulatory requirements.
- •Whose treating neurologist at the RMMSC feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent.
排除标准
- •Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion.
- •Has previously not participated in the SaROD trial at the RMMSC site.
- •Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC.
研究组 & 干预措施
Home infusion of ocrelizumab
Experimental
Patients will receive infusion of ocrelizumab at home, instead of at clinic.
干预措施: Ocrelizumab at home (Drug)
结局指标
主要结局
Severe infusion reactions
时间窗: 24 hours after infusion
Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Infusion reactions
时间窗: 24 hours after infusion
Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology
次要结局
- Adverse events(2 months)
- Severe infusion reactions compared to historic controls.(24 hours after infusion)
- Infusion reactions compared to historic controls.(24 hours after infusion)
- Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical(2 months)
- Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental(2 months)
- Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety(2 months)
- Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression(2 months)
- Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)(2 months)
研究者
研究点 (1)
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