Clinical Trials

Biogen Multiple Sclerosis Pregnancy Exposure Registry

Type of Study/Intervention


Recruitment Status


Form of MS

Relapsing remitting MS

Brief summary

To collect and evaluate safety data on TecfideraTM (dimethyl fumarate) exposure during pregnancy.

Tecfidera has not been tested in clinical trials in pregnant women and the side-effects are unknown. Tecfidera is not recommended for pregnant women however, this study will capture vital data on pregnancies that may have been inadvertently exposed to Tecfidera.

The purpose of the Multi-National Tecfidera Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess side-effects in pregnant women and in the offspring of women exposed to Tecfidera during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, foetal, and infant outcomes and compare it with reference populations.

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 registry.


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