NCT04855617已完成不适用
Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores
研究概览
简要总结
This study is designed to determine whether symptom burden differs by time to infusion.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Diagnosis of multiple sclerosis (revised 2017 criteria)
- •Plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for >12 months as part of their clinical care
- •Individual must be able to provide consent, read/write/comprehend English Language
排除标准
- •Clinical relapse within 3 months of first on-study infusion
- •Cognitive impairment limiting the ability to consent or fill out the electronic survey
- •Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- •Untreated psychiatric illness (such as major depressive disorder, Bipolar disorder, psychotic disorder, schizophrenia)
- •Active substance abuse disorder
- •Significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection)
- •Chemotherapy use within 6 months of first study infusion
- •Prior treatment with alemtuzumab within 12 months of first study infusion
- •Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion
研究组 & 干预措施
Patients Receiving Multiple Sclerosis care
Patients currently receiving ocrelizumab or initiating ocrelizumab per their MS treating physician.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Change in Quality of Life in Neurologic Disorders (NeuroQoL) Scores
时间窗: Week 4, Week 22
The NeuroQoL short form will be used for this study, which consists of 5 statements on how much difficulty one currently has during certain activities. Each statement is answered on a scale of 1 (cannot do) to 5 (none); the total range of score is 1-25. The higher the score, the less difficulty one has.
次要结局
- Change in Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) Scores(Week 4, Week 22)
- Change in SymptoMScreen (SyMS) Scores(Week 4, Week 22)
研究者
研究点 (2)
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