The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Fingolimod
- Conditions
- Multiple Sclerosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Frequency of major malformations associated with exposure to fingolimod during pregnancy
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility 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
- •There are no specific exclusion criteria for this registry.
Arms & Interventions
fingolimod
prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod
Intervention: Fingolimod
Outcomes
Primary Outcomes
Frequency of major malformations associated with exposure to fingolimod during pregnancy
Time Frame: Up to 23 months
Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.
Frequency of minor congenital malformations associated to fingolimod during pregnancy
Time Frame: Up to 23 months
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.
Secondary Outcomes
- Number of spontaneous abortions, stillbirths and elective terminations;(Up to 23 months)
- Frequency of specific types of major and minor congenital malformations 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(Up to 23 months)