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The Gilenya Pregnancy Registry

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis

Interventions: Fingolimod

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia

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 overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (61)

Fort Lauderdale, Florida, United States
Cambridge, Massachusetts, United States
Grand Forks, North Dakota, United States
Bahía Blanca, Buenos Aires, Argentina
Córdoba, Argentina
Box Hill, Victoria, Australia
Graz, Austria
Linz, Austria
Brasschaat, Belgium
Leuven, Belgium
Rio de Janeiro, Rio de Janeiro, Brazil
Saint-Laurent, Quebec, Canada
Bogotá, Colombia
Nicosia, Cyprus
Ostrava-Poruba, Czechia
Aalborg, Denmark
Aarhus, Denmark
Copenhagen, Denmark
Sønderborg, Denmark
Tampere, Finland
Turku, Finland
Bron, France
Cahors, France
Bochum, Germany
Athens, GR, Greece
Budapest, HUN, Hungary
Győr, Hungary
Dublin, Ireland
Jerusalem, Israel
Ramat Gan, Israel
+ 31 more on CT.gov