跳至主要内容
临床试验/NCT07566988
NCT07566988已完成不适用

Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 2,604 人开始时间: 2024年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,604
试验地点
1

研究概览

简要总结

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

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

Pooled OMB Cohort

Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OMB from August 20, 2020.

Pooled OCR Cohort

Adult MS patients, including treatment-naïve and treatment-experienced patients, with a first claim for OCR from August 20, 2020.

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.

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.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验