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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,089
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Many locations
Multiple Locations, Finland
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
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
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Elective TOPFA for other reasons than IFN-β exposure
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
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Elective termination for other reasonsthan IFN-β exposure
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
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Stillbirth due to different regimes of IFN-β exposure
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
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Live birth while different regimes of IFN-β exposure
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
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Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
MCA due to different regimes of IFN-β exposure
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
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
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
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)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
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)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
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)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
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)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
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)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
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)
Time frame: 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
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3. Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)
Time frame: 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
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3. Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of elective TOPFA stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of stillbirth stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of live birth stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of MCA stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Time frame: 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
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years