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EPID Multiple Sclerosis Pregnancy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749396
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
EPID Research
Biogen
Merck Serono Europe Ltd
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG Drug: Extavia (interferon beta-1b), Novartis Pharma AG Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd Drug: Avonex (interferon beta-1a), Biogen Idec Ltd Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) Other: No MSDMDs therapy (control)

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 2089 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : August 14, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IFN-β / Cohort 1
Exposure to IFN-β only
Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Extavia (interferon beta-1b), Novartis Pharma AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Avonex (interferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2
Women with MS exposed to IFN-β regardless of exposure to other MSDMDs
Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Extavia (interferon beta-1b), Novartis Pharma AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: Avonex (interferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

No MSDMDs / Cohort 3
Women with MS exposed with no exposure to any MSDMDs
Other: No MSDMDs therapy (control)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

No IFN-β + other MSDMDs / Cohort 4
Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs
Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Other MSDMDs / Cohort 5
Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera)
Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Control / Cohort 6
Women from the general population without MS



Primary Outcome Measures :
  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 ]
    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)

  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 ]
    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)

  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 ]
    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)

  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 ]
    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)

  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 ]
    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)

  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 ]
    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)


Secondary Outcome Measures :
  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 ]
    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)

  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 ]
    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)

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The target study population consists of Finnish, Swedish and Norwegian women diagnosed with MS who have been pregnant during the study period from 1996 to 2014. The pregnancy may have resulted in an induced abortion, spontaneous abortion, ectopic pregnancy, stillbirth, or live birth during the study period.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749396


Locations
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Finland
Many locations
Multiple Locations, Finland
Sponsors and Collaborators
Bayer
EPID Research
Biogen
Merck Serono Europe Ltd
Novartis Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02749396    
Other Study ID Numbers: 18219
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic