EPID Multiple Sclerosis Pregnancy Study

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.

Conditions

• Multiple Sclerosis

Interventions

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)

DRUG

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

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

OTHER

No MSDMDs therapy (control)

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

Sponsors & Collaborators

• EPID Research

  collaborator UNKNOWN

• Biogen

  collaborator INDUSTRY

• Merck Serono Europe Ltd

  collaborator UNKNOWN

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Bayer

  lead INDUSTRY

Principal Investigators

• Bayer Study Director · Bayer

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-02

Primary Completion

2018-08-14

Completion

2018-08-14

Countries

• Finland