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临床试验/NCT04478591
NCT04478591已完成不适用

The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2020年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
1
主要终点
Wearing-off symptoms

研究概览

简要总结

The primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.

详细描述

Ocrelizumab is a monoclonal antibody very effective for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. Ocrelizumab is usually administered intravenous every six months. Natalizumab is another type of treatment used for relapsing-remitting multiple sclerosis and is administered every four weeks. Often patients report MS-related symptoms just prior to their next infusion such as fatigue, coordination problems or motor problems, the so-called wearing-off phenomenon. The exact etiology of this phenomenon remains unknown. Although not studied before, patients do report similar symptoms when using ocrelizumab. Furthermore, because of the COVID-19 pandemic, some patients receive extended dosing of ocrelizumab based on b-cell count. Whether this can increase wearing-off symptoms is unknown.

The goal of this research is to study the prevalence of wearing-off symptoms and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab. All patients using ocrelizumab during one year or more that provided written informed consent to participate in the study will be asked to complete three questionnaires before or during their next treatment with ocrelizumab. The questionnaires that will be used are the MSIS-29, the treatment satisfaction questionnaire and a questionnaire about wearing-off symptoms. Exact weight of the participants will be measured. Information about age, gender, date of diagnosis, start date of ocrelizumab, clinical and radiological disease activity, EDSS score, b-cell count and the biomarker neurofilament light will be extracted from the patient files. After two weeks, participants receive two additional digital questionnaires, the MSIS-29 and a follow-up questionnaire about wearing-off symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Diagnosis multiple sclerosis
  • Use of ocrelizumab as a treatment for multiple sclerosis for a minimum of one year

排除标准

  • Unable to answer questionnaires in Dutch
  • Different infusion protocol during the previous ocrelizumab infusion (e.g. 300 mg of ocrelizumab instead of 600 mg).

结局指标

主要结局

Wearing-off symptoms

时间窗: Baseline

Prevalence of wearing-off symptoms prior to ocrelizumab infusion (yes/no assessed on questionnaires)

次要结局

  • % of wearing-off symptoms (yes/no assessed on questionnaires) in correlation to the % of patients with extended dosing versus standard dosing with ocrelizumab.(At baseline (prior to next infusion with ocrelizumab))
  • Self-reported disability (MSIS-29 questionnaire) compared before and after ocrelizumab infusion in patients with wearing-off symptoms(At baseline (prior to next infusion with ocrelizumab) and after two weeks)
  • Self-reported disability (MSIS-29 questionnaire) after ocrelizumab infusion in patients without wearing-off symptoms(At baseline (prior to next infusion with ocrelizumab) and after two weeks)
  • Neurofilament light levels in patients with wearing-off symptoms.(At baseline (prior to next infusion with ocrelizumab))
  • Absolute B-cells count in blood in correlation to the presence of wearing-off symptoms (yes/no assessed on questionnaires)(At baseline (prior to next infusion with ocrelizumab))
  • Type of multiple sclerosis (either RRMS or PPMS) in correlation to % of patients with wearing-off symptoms (yes/no assessed on questionnaires).(At baseline (prior to next infusion with ocrelizumab))
  • Treatment satisfaction score measured by the treatment satisfaction questionnaire in correlation to the % of patients with wearing-off symptoms (yes/no assessed on questionnaires)(At baseline (prior to next infusion with ocrelizumab))
  • Change of wearing-off symptoms after ocrelizumab infusion in patients with wearing-off symptoms(Two weeks after ocrelizumab infusion)
  • Post-dose symptoms after ocrelizumab infusion(Two weeks after ocrelizumab infusion)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoé van Kempen

principal investigator

Amsterdam UMC, location VUmc

研究点 (1)

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