INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
研究概览
简要总结
Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a diagnosis of MS disease, regardless of MS clinical type, recorded at least once during the full study period.
- •Women with at least one recorded pregnancy after the MS diagnosis (including pregnancies ending in live birth, stillbirth, spontaneous abortion, ectopic pregnancy, or elective termination)
排除标准
- 未提供
研究组 & 干预措施
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Avonex (IFNβ-1-a, Biogen Netherlands B.V) (Drug)
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Rebif (IFNβ-1-a, Merck Europe B.V.) (Drug)
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG) (Drug)
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Rebif (IFNβ-1-a, Merck Europe B.V.) (Drug)
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Avonex (IFNβ-1-a, Biogen Netherlands B.V) (Drug)
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: MS disease modifying drugs (MSDMDs) (Drug)
Pregnancies unexposed to IFNB (regardless of other MSDMDs)
No dispensed IFNB during the pre-pregnancy period nor any time during pregnancy, regardless of other MSDMDs
Outcomes:
干预措施: MS disease modifying drugs (MSDMDs) (Drug)
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Extavia (IFNβ-1-b, Novartis Europharm Limited) (Drug)
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V) (Drug)
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Extavia (IFNβ-1-b, Novartis Europharm Limited) (Drug)
Pregnancies unexposed to IFNB nor other MSDMDs
No dispensed IFNB nor any other MSDMDs during the pre-pregnancy period nor any time during pregnancy
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V) (Drug)
Pregnancies exposed to IFNB (regardless of other MSDMDs)
With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
干预措施: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG) (Drug)
结局指标
主要结局
The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
时间窗: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
Analysis groups: Pregnancies exposed to IFNB only group and Pregnancies unexposed to IFNB nor other MSDMDs group
The level of precision for the risk of pre-defined adverse pregnancy outcomes in late pregnancy that can be obtained with the available number of exposed and unexposed pregnancies
时间窗: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
Pre-defined adverse pregnancy outcomes: * Anomalies: Major congenital anomalies (MCA); All anomalies, including minor and major * Fatal outcomes: Spontaneous abortions, Elective terminations, Stillbirth and Neonatal mortality * Growth outcomes: Small for gestation age and Low birth weight * Other outcomes: Preterm birth Late pregnancy, i.e. the 2nd and 3rd trimester.
The annual number of pregnancies of women with MS in the exposure groups
时间窗: Data recorded between 2015-2019 and 2020-2022.
Analysis in Pregnancies exposed to IFNB only group.
次要结局
- The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs(Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.)
- The annual number of women with MS in childbearing age, and with dispensed IFNB(Data recorded between 2015 to 2022 in Finland and Sweden)