The Gilenya Pregnancy Registry
The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
ClinicalTrials.gov Identifier: NCT01285479
Novartis Reference Number: CFTY720D2404
Last Update: Mar 13, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.
Any woman with a diagnosis of MS
Any woman currently pregnant
Exposure to fingolimod during pregnancy or up to 8 weeks before LMP
Signed informed consent
There are no specific exclusion criteria for this registry.