Brief summary

To collect and evaluate safety data on Gilenya exposure immediately before (up to 8 weeks before last menstrual period) and during pregnancy.

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

The purpose of the Multi-National Gilenya 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 Gilenya 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 Gilenya during the pregnancy or up to  8 weeks before last menstrual period.

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 on clinicaltrials.gov.

Region

All States and Territories

Last updated

19 Nov 2020