Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Time to treatment initiation
研究概览
简要总结
The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.
详细描述
This study will be a two-center retrospective/observational analysis with data collected from the Research Patient Data Registry (RPDR), Brigham Multiple Sclerosis Center Patient Database (Oracle), and Boston Medical Center MS Clinic Database (BMC-MS).
Using the Oracle database, BMC-MS database and electronic medical records (EPIC), the investigators will capture all MS patients who satisfy inclusion criteria. This study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (EDSS), and functional systems scores (FSS) where available.
Additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and MRI scan results.
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
- 否
入选标准
- •All MS patients at the Brigham MS Center and Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.
排除标准
- •Simultaneous use of high dose monthly IV steroids,
- •Secondary progressive MS (SPMS) disease category,
- •Additional serious medical or neurologic co-morbid diseases,
- •Additional concomitant immunosuppressive therapy of any kind,
- •Additional concomitant MS-specific therapy (DMT) of any kind,
- •Change of infusion or care site and absence of neurologic or imaging follow-up.
研究组 & 干预措施
Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital
All MS patients at the Brigham MS Center who have been diagnosed with relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS), ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.
干预措施: Ocrelizumab (Drug)
Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center
All MS patients at the Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Time to treatment initiation
时间窗: 03/2017 - 07/2021
Time from diagnosis to Ocrelizumab treatment initiation in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.
次要结局
- Annualized relapse rate(12-24 months from ocrelizumab initiation)
- MRI Changes(12-24 months from ocrelizumab initiation)
研究者
Maria Houtchens
Neurologist, Director of the Clinical Care, Multiple Sclerosis Center
Brigham and Women's Hospital