Clinical Trials

Biogen Multiple Sclerosis Pregnancy Exposure Registry

Type of Study/Intervention

Observational

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS

Brief summary

The Biogen Multiple Sclerosis Pregnancy Exposure Registry is a prospective, observational registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. Women of childbearing potential are a considerable segment of the patient population affected by MS and are likely to be exposed to a Registry-specified Biogen MS product around the time of conception and during pregnancy. Biogen completed pregnancy registries for Avonex and Tysabri; however, formal studies in pregnant women have not been conducted. Therefore, it is important to evaluate, in a global Pregnancy Registry, how exposure to a marketed Biogen MS product specified in this Pregnancy Registry may affect pregnancy and infant outcomes. Data will be collected on prospective pregnancies (i.e. enrollment prior to knowledge of outcome) at time of enrollment, 6 to 7 months gestation, and approximately 4,12, and 52 weeks after estimated date of delivery. The prevalence of spontaneous abortions, birth defects, and other pregnancy and infant outcomes will be calculated and compared to background rates from external sources such as the European Surveillance of Congenital Anomalies.

The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).

Inclusion criteria

Any woman with a diagnosis of MS, who is currently pregnant and has been exposed to Tecfidera during the pregnancy.

Anticipated start date

June 2014

Recruitment contacts

Daniel Merlo
Eastern Health MS Service
Level 2, 5 Arnold St Box Hill VIC 3128
Email: [email protected]
Phone: 03 9895 4914

Further details

Full details of the trial can be found on the ClinicalTrials.gov registry.

Region

All States and Territories

Last updated

12/12/2019

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