EPID Multiple Sclerosis Pregnancy Study

• Status: Completed
• Trial end date: 2018-08-14
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Collaborators: Biogen; EPID Research; Merck Serono Europe Ltd; Novartis Pharmaceuticals
• Treatments: Interferon beta-1a; Interferon beta-1b; Interferon-beta; Interferons

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.