Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,089
- 试验地点
- 1
- 主要终点
- Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
研究概览
简要总结
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
详细描述
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include information on all stillbirths of foetuses with a birth weight of at least 500 g or with a gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on stillbirths after 28 GW
The estimated number of pregnancies in MS patients needed is 1671, encompassing data from:
i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
排除标准
- 未提供
研究组 & 干预措施
IFN-β / Cohort 1
Exposure to IFN-β only
干预措施: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG (Drug)
IFN-β / Cohort 1
Exposure to IFN-β only
干预措施: Extavia (interferon beta-1b), Novartis Pharma AG (Drug)
IFN-β / Cohort 1
Exposure to IFN-β only
干预措施: Rebif (interferon beta-1a), Merck Serono Europe Ltd (Drug)
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
干预措施: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) (Drug)
IFN-β / Cohort 1
Exposure to IFN-β only
干预措施: Plegridy (peginterferon beta-1a), Biogen Idec Ltd (Drug)
IFN-β / Cohort 1
Exposure to IFN-β only
干预措施: Avonex (interferon beta-1a), Biogen Idec Ltd (Drug)
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
干预措施: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG (Drug)
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
干预措施: Extavia (interferon beta-1b), Novartis Pharma AG (Drug)
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
干预措施: Rebif (interferon beta-1a), Merck Serono Europe Ltd (Drug)
IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
干预措施: Avonex (interferon beta-1a), Biogen Idec Ltd (Drug)
No MSDMDs / Cohort 3
Women with MS exposed with no exposure to any MSDMDs
干预措施: No MSDMDs therapy (control) (Other)
No IFN-β + other MSDMDs / Cohort 4
Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs
干预措施: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) (Drug)
Other MSDMDs / Cohort 5
Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera)
干预措施: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) (Drug)
结局指标
主要结局
Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective TOPFA for other reasons than IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective termination for other reasonsthan IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Stillbirth due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Live birth while different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
MCA due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
时间窗: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
次要结局
- Prevalence of stillbirth stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of live birth stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of MCA stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)
- Prevalence of elective TOPFA stratified by specific patient characteristics(Retrospective Data analysis: MS patients data encompassing approximately 19 years)