check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

18219

ClinicalTrials.gov Identifier:

NCT02749396

EudraCT Number:

Not Available

EU CT Number:

Not Available
EPID Multiple Sclerosis Pregnancy Study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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.

Trial summary

Enrollment Goal
2089
Trial Dates
May 2016 - August 2018
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Finland

Primary Outcome

  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Retrospective Data analysis: MS patients data encompassing approximately 19 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon β – a register-based study in the Nordic countries
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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