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Completed

NCT Number: NCT02749396

EPID Multiple Sclerosis Pregnancy Study

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Extavia (interferon beta-1b), Novartis Pharma AG

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Rebif (interferon beta-1a), Merck Serono Europe Ltd

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Plegridy (peginterferon beta-1a), Biogen Idec Ltd

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Avonex (interferon beta-1a), Biogen Idec Ltd

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)

Drug

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

No MSDMDs therapy (control)

Other

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Primary outcomes

  1. 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

    Time frame: 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

  2. Elective TOPFA for other reasons than IFN-β exposure

    Time frame: 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

  3. Elective termination for other reasonsthan IFN-β exposure

    Time frame: 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

  4. Stillbirth due to different regimes of IFN-β exposure

    Time frame: 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

  5. Live birth while different regimes of IFN-β exposure

    Time frame: 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

  6. MCA due to different regimes of IFN-β exposure

    Time frame: 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

  7. 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

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

  8. Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

  9. Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

  10. Comparison of the prevalence of live birth due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

  11. Comparison of the prevalence of MCA due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

  12. Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)

Secondary outcomes

  1. Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
    • Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)

  2. Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),
    • Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
    • Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)

  3. Prevalence of elective TOPFA stratified by specific patient characteristics

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    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

  4. Prevalence of stillbirth stratified by specific patient characteristics

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    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

  5. Prevalence of live birth stratified by specific patient characteristics

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    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

  6. Prevalence of MCA stratified by specific patient characteristics

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    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

  7. Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure

    Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Biogen
  • EPID Research
  • Merck Serono Europe Ltd
  • Novartis Pharmaceuticals

Registry information

Official study title

Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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