Last Update: Mar 15, 2024
The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
ClinicalTrials.gov Identifier:
Novartis Reference Number:CFTY720D2404
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Multiple Sclerosis
Recruiting
500
Oct 15, 2011
Jan 02, 2031
Female
- (Child, Adult, Older Adult)

Interventions

Drug

Fingolimod

fingolimod 0.5 mg/day, including generic versions of fingolimod

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.

Study Location

Novartis Investigative Site

Recruiting

Cordoba,X5000FAL,Argentina

Novartis Investigative Site

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Bahía Blanca,Buenos Aires,8000,Argentina

Novartis Investigative Site

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Box Hill,Victoria,3128,Australia

Novartis Investigative Site

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Linz,4020,Austria

Novartis Investigative Site

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Graz,8036,Austria

Novartis Investigative Site

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Leuven,3000,Belgium

Novartis Investigative Site

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Brasschaat,2930,Belgium

Novartis Investigative Site

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Rio de Janeiro,RJ,21941-913,Brazil

Novartis Investigative Site

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Saint-Laurent,Quebec,H4M-2P4,Canada

Novartis Investigative Site

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Bogotá,Colombia

Novartis Investigative Site

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Nicosia,1683,Cyprus

Novartis Investigative Site

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Ostrava-Poruba,708 52,Czech Republic

Novartis Investigative Site

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Soenderborg,6400,Denmark

Novartis Investigative Site

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Aalborg,9000,Denmark

Novartis Investigative Site

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Aarhus,8000 C,Denmark

Novartis Investigative Site

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Copenhagen,DK-2100,Denmark

Novartis Investigative Site

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Tampere,FIN-33521,Finland

Novartis Investigative Site

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Turku,20520,Finland

Novartis Investigative Site

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Cahors,50269,France

Novartis Investigative Site

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Bron,69677,France

Novartis Investigative Site

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Bochum,44791,Germany

Novartis Investigative Site

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Athens,GR,115 25,Greece

Novartis Investigative Site

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Budapest,HUN,1204,Hungary

Novartis Investigative Site

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Gyor,H-9023,Hungary

Novartis Investigative Site

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Dublin 4,D04 T6F,Ireland

Novartis Investigative Site

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Ramat Gan,52621,Israel

Novartis Investigative Site

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Jerusalem,9112001,Israel

Novartis Investigative Site

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Milano,MI,20132,Italy

Novartis Investigative Site

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Firenze,FI,50134,Italy

Novartis Investigative Site

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Catania,CT,95123,Italy

Novartis Investigative Site

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Genova,GE,16132,Italy

Novartis Investigative Site

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Roma,RM,189,Italy

Novartis Investigative Site

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Orbassano,TO,10043,Italy

Novartis Investigative Site

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Beirut,1107 2020,Lebanon

Novartis Investigative Site

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Mexico,Distrito Federal,05300,Mexico

Novartis Investigative Site

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Amsterdam,Netherlands

Novartis Investigative Site

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Lubin,20-089,Poland

Novartis Investigative Site

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Warszawa,02-957,Poland

Novartis Investigative Site

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Amadora,2720-276,Portugal

Novartis Investigative Site

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Porto,4099-001,Portugal

Novartis Investigative Site

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Bucharest,050098,Romania

Novartis Investigative Site

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Moscow,127018,Russian Federation

Novartis Investigative Site

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Jeddah,21499,Saudi Arabia

Novartis Investigative Site

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Riyadh,11211,Saudi Arabia

Novartis Investigative Site

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Bratislava,Slovak Republic,811 07,Slovakia

Novartis Investigative Site

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Maribor,2000,Slovenia

Novartis Investigative Site

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Sevilla,Andalucia,41071,Spain

Novartis Investigative Site

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Madrid,28222,Spain

Novartis Investigative Site

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Goeteborg,413 45,Sweden

Novartis Investigative Site

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Bern,3010,Switzerland

Novartis Investigative Site

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St Gallen,9007,Switzerland

Novartis Investigative Site

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Basel,4031,Switzerland

Novartis Investigative Site

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Lausanne,1011,Switzerland

Novartis Investigative Site

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Abu Dhabi,United Arab Emirates

Novartis Investigative Site

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Newcastle upon Tyne,NE1 4LP,United Kingdom

Novartis Investigative Site

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Norwich,NR1 3SR,United Kingdom

Novartis Investigative Site

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Nottingham,NG7 2UH,United Kingdom

Novartis Investigative Site

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Grand Forks,North Dakota,58201,United States

Novartis Investigative Site

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Cambridge,Massachusetts,02139,United States

Novartis Investigative Site

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Fort Lauderdale,Florida,33308,United States

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