Brief summary

To collect and evaluate safety data on Aubagio exposure prior to and during pregnancy.

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

The purpose of the International Pregnancy Exposure Registry of Women with MS Exposed to Aubagio is to continuously monitor, evaluate, and assess side-effects in pregnant women and in the offspring of women exposed to Aubagio before and 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 Aubagio during the pregnancy OR exposed to Aubagio prior to pregnancy and with a detectable blood plasma level of at least 0.02mg/L during pregnancy.

Anticipated start date

Commenced

Recruitment contacts

Daniel Merlo
Eastern Health MS Service.
Level 2, 5 Arnold St Box Hill, VIC 3128
Email: msservice@easternhealth.org.au
Phone: 03 9895 4914

Further details

Full details of the trial can be found here

Region

ACT, NSW, NT, NZ, SA, TAS, QLD, VIC, WA.

Last updated

19 Nov 2020