The Gilenya Pregnancy Registry

Study Overview
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Brief Summary
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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.

Official Title
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The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod


Participation Criteria
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Eligibility Criteria
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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: There are no specific exclusion criteria for this registry.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fingolimod<br>prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod | Drug: Fingolimod<br>* fingolimod 0.5 mg/day, including generic versions of fingolimod<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of major malformations associated with exposure to fingolimod during pregnancy | Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized. | Up to 23 months | 
| Frequency of minor congenital malformations associated to fingolimod during pregnancy | 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. | Up to 23 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy | Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected | Up to 23 months | 
| Number of spontaneous abortions, stillbirths and elective terminations; | 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 | Up to 23 months | 
| Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age | 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 | Up to 23 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fingolimod, FTY720, Gilenya, Multiple sclerosis, MS, Safety, Pregnancy, Pregnancy outcomes