EPID Multiple Sclerosis Pregnancy Study

Bayer

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Extavia (interferon beta-1b), Novartis Pharma AG; Drug: Avonex (interferon beta-1a), Biogen Idec Ltd; Other: No MSDMDs therapy (control); Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046); Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd; Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG; Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02749396

18219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,089 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,089 participants in 6 patient groups

IFN-β / Cohort 1

Description:

Exposure to IFN-β only

Treatment:

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

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

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

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

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

IFN-β + other MSDMDs / Cohort 2

Description:

Women with MS exposed to IFN-β regardless of exposure to other MSDMDs

Treatment:

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

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

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

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

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

No MSDMDs / Cohort 3

Description:

Women with MS exposed with no exposure to any MSDMDs

Treatment:

Other: No MSDMDs therapy (control)

No IFN-β + other MSDMDs / Cohort 4

Description:

Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs

Treatment:

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

Other MSDMDs / Cohort 5

Description:

Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera)

Treatment:

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

Control / Cohort 6

Description:

Women from the general population without MS