EPID Multiple Sclerosis Pregnancy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-02

Study Completion Date

2018-08-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IFN-β / Cohort 1

Exposure to IFN-β only

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

No MSDMDs therapy (control)

Intervention Type OTHER

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

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

Intervention Type DRUG

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)

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

Intervention Type DRUG

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

Control / Cohort 6

Women from the general population without MS

No interventions assigned to this group

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

No MSDMDs therapy (control)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes