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.

The Gilenya Pregnancy Registry

Multiple Sclerosis

Fingolimod

The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.

Minor congenital malformations:

* Minor anomalies, i.e., anomalies with no serious medical or cosmetic consequence to the child.
* Positional deformities, i.e., a positional deformity that usually normalizes spontaneously after about 3 months of age, e.g., abnormal head shape, torticollis.
* Features of pre-maturity.
* Chromosome abnormalities.
* Genetic disorders.

Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected

Number of spontaneous abortions, stillbirths and elective terminations will be collected to characterize the nature of pregnancy and other fetal outcomes associated with exposure to fingolimod during pregnancy

Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age associated with exposure to fingolimod during pregnancy

prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod

The Gilenya Pregnancy Registry

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?