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The Gilenya Pregnancy Registry

NCT01285479 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 312

Last updated 2025-01-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fingolimod

fingolimod 0.5 mg/day, including generic versions of fingolimod

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-15
Primary Completion
2024-05-29
Completion
2024-05-29

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Lebanon
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Saudi Arabia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • United Arab Emirates
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285479 on ClinicalTrials.gov