Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,607
- 试验地点
- 1
- 主要终点
- Proportion of Patients With ≥1 DMT Claim During Pregnancy
研究概览
简要总结
This study aims to assess the real-world patterns of disease modifying therapy (DMT) use before, during, and after pregnancy in women with multiple sclerosis (MS). The study will use a pooled closed claims database containing closed payer medical and pharmacy claims data for patients in the United States (US).
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 回顾性
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- ≥1 claim with a diagnosis or procedure code for live birth during the patient identification period (index date). o Note: For patients with more than one pregnancy in the patient identification period, all eligible pregnancies will be included.
- Female sex recorded on enrollment record overlapping with index date.
- Aged between 18 and 49 years old at index date.
- ≥2 claims with an MS diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code G35) ≥30 days apart in the pre-conception or pregnancy periods.
- Continuous healthcare plan enrollment from ≥6 months prior to the conception date to ≥6 months following the index date.
排除标准
- Pregnancies involving multiples, subject to data availability.
- Malignancy in pre-conception, pregnancy, or post-delivery periods.
研究组 & 干预措施
MS Group
Women with MS who experienced at least one live birth between August 20, 2020 and September 30, 2024.
结局指标
主要结局
Proportion of Patients With ≥1 DMT Claim During Pregnancy
时间窗: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients With ≥1 DMT Claim During the Post-Delivery Period
时间窗: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Proportion of Patients With ≥1 DMT Claim During the Pre-Conception Period
时间窗: 6 months prior to the estimated conception date
次要结局
- Proportion of Patients by Sequences of DMTs Used During the Pre-Conception Period(6 months prior to the estimated conception date)
- Proportion of Patients by Sequences of DMTs Used During Pregnancy(Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period))
- Proportion of Patients by Sequences of DMTs Used During the Post-Delivery Period(Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years)
- Proportion of Patients by DMT Use During Pregnancy(Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period))
- Proportion of Patients by DMT Use During the Post-Delivery Period(Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years)
- Proportion of Patients by Demographic and Clinical Characteristics(6 months prior to the estimated conception date)
- DCCI Score(6 months prior to the estimated conception date)
- Number of PDG Mental Health Disorders(6 months prior to the estimated conception date)
- Age(6 months prior to the estimated conception date)
- Proportion of Patients by DMT Use During the Pre-Conception Period(6 months prior to the estimated conception date)
- Time to First Observed DMT Claim in the Post-Delivery Period(Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07844070
- 其他研究编号
- COMB157GUS41
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (29天后)
- 研究完成日期
- (29天后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否