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The Gilenya Pregnancy Registry

Not Recruiting
years of age
Female
Phase N/A

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Overview

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.

Eligibility

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 details

Multiple Sclerosis

NCT01285479

Novartis Pharmaceuticals

26 January 2025

FAQs

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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