The Gilenya Pregnancy Registry

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT01285479
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-28
• Study Start: 2011-10-15
• Status Verified: 2024-03
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 312

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fingolimod	Fingolimod	prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod

Primary Outcome Measures

Name	Time	Method
Frequency of major malformations associated with exposure to fingolimod during pregnancy	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	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 Outcome Measures

Name	Time	Method
Number of spontaneous abortions, stillbirths and elective terminations;	Up to 23 months	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
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy	Up to 23 months	Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected
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	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Nottingham, United Kingdom