A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients
2026年5月6日 更新者:Novartis Pharmaceuticals
Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims database.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
2604
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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East Hanover、New Jersey、美国、07936
- Novartis
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adult patients who had a first claim for either ofatumumab or ocrelizumab from August 20, 2020, with no claim for either drug during the preceding 12 months.
描述
Inclusion criteria:
Pooled OMB and OCR Cohorts:
- ≥1 incident claim for OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) in the patient identification period (index date = first claim date).
- No claims for OMB or OCR within the 12 months prior to the index date.
- ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with a diagnosis of MS in the first position in the 12 months prior to or on index date.
- ≥18 years of age on index date.
- Continuous healthcare plan enrollment for ≥12 months prior to index date (baseline period) and ≥6 months after index date (follow-up period).
- Persistent use of OMB (Pooled OMB Cohort) or OCR (Pooled OCR Cohort) for ≥6 months after index date.
Treatment-naïve OMB and OCR Cohorts:
- Included in Pooled OMB Cohort or Pooled OCR Cohort.
- No claims for a disease modifying therapy (DMT) used for the treatment of MS within the 12-month baseline period.
Exclusion criteria:
• None.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Pooled OMB Cohort
Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020.
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Pooled OCR Cohort
Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020.
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Treatment-naïve OMB Cohort
Adult MS patients who initiated OMB treatment and who did not use a DMT for MS treatment in the 12-month period before starting OMB.
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Treatment-naïve OCR Cohort
Adult MS patients who initiated OCR treatment and who did not use a DMT for MS treatment in the 12-month period before starting OCR.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Annualized Relapse Rate (ARR) in Treatment-Naïve Patients
大体时间:Up to approximately 3 years and 11 months
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ARR was defined as the number of relapse episodes per patient-year (PPY) during the follow-up period.
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Up to approximately 3 years and 11 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ARR in All Patients
大体时间:Up to approximately 3 years and 11 months
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ARR was defined as the number of relapse episodes per PPY during the follow-up period.
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Up to approximately 3 years and 11 months
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Healthcare Visits PPY
大体时间:Up to approximately 3 years and 11 months
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Healthcare visits included IP stays, OP visits, and emergency department visits.
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Up to approximately 3 years and 11 months
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Inpatient Days PPY
大体时间:Up to approximately 3 years and 11 months
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Up to approximately 3 years and 11 months
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Difference in Healthcare Costs in OMB Versus OCR
大体时间:Up to approximately 3 years and 11 months
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Healthcare costs included IP, OP, emergency department, and pharmacy costs.
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Up to approximately 3 years and 11 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Novartis Pharmaceuticals、Novartis Pharmaceuticals
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年10月25日
初级完成 (实际的)
2025年4月30日
研究完成 (实际的)
2025年4月30日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- COMB157GUS37
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.