The Gilenya Pregnancy Registry

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Observational

Funder types: Industry

Identifiers

NCT01285479

CFTY720D2404

Details and patient eligibility

About

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.

Enrollment: 312 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

312 participants in 1 patient group

fingolimod

Description:

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

Treatment:

Drug: Fingolimod