The Gilenya Pregnancy Registry
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
There are no specific exclusion criteria for this registry.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Multiple Sclerosis
Participants needed
500
Est. Completion Date
Jan 2, 2031
Treatment type
Observational [Patient Registry]
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT01285479
Study number
CFTY720D2404
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