The Gilenya Pregnancy Registry

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01285479

Run by

Novartis Pharmaceuticals

People needed

312

Starts

2011-10-15

Expected to finish

2024-05-29

Last updated by the study team

2025-01-22

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• There are no specific exclusion criteria for this registry.

Where it is running

• Novartis Investigative Site — Cambridge, Massachusetts, United States
• Novartis Investigative Site — Grand Forks, North Dakota, United States
• Novartis Investigative Site — Bahía Blanca, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Box Hill, Victoria, Australia
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Brasschaat, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Saint-Laurent, Quebec, Canada
• Novartis Investigative Site — Bogotá, Colombia
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Ostrava-Poruba, Czechia
• Novartis Investigative Site — Aalborg, Denmark
• Novartis Investigative Site — Aarhus, Denmark
• Novartis Investigative Site — Copenhagen, Denmark
• Novartis Investigative Site — Sønderborg, Denmark
• Novartis Investigative Site — Tampere, Finland
• Novartis Investigative Site — Turku, Finland
• Novartis Investigative Site — Bron, France
• Novartis Investigative Site — Cahors, France
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Athens, GR, Greece
• Novartis Investigative Site — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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