The Gilenya Pregnancy Registry

The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

ClinicalTrials.gov Identifier: NCT01285479

Novartis Reference Number: CFTY720D2404

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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 Gilenya before (up to 8 weeks before last menstrual period) 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.

Condition 
Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
500 participants
Start date 
Oct 15, 2011
Completion date 
Jan 01, 2031
Gender 
Female
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
Fingolimod
Other
fingolimod

Eligibility Criteria

Inclusion Criteria:

Pregnancy and reported confirmed or suspected maternal exposure to Gilenya any time during pregnancy or shortly before pregnancy (up to 8 weeks before LMP).
Informed consent

Exclusion Criteria:

There are no specific exclusion criteria for this registry.

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
Recruiting
Cambridge, 02139
Massachusetts
United States
Novartis Investigative Site
Recruiting
Grand Forks, 58201
North Dakota
United States
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5000FAL
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Box Hill, 3128
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
Novartis Investigative Site
Recruiting
Linz, A-4020
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Brasschaat, 2930
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Novartis Investigative Site
Withdrawn
Melsbroek, 1820
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Saint-Laurent, H4M-2P4
Quebec
Canada
Cyprus
Novartis Investigative Site
Recruiting
Nicosia, 1683
-
Cyprus
Czechia
Novartis Investigative Site
Recruiting
Ostrava-Poruba, 708 52
-
Czechia
Denmark
Novartis Investigative Site
Recruiting
Aarhus, 8000 C
-
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, DK-2100
-
Denmark
Novartis Investigative Site
Recruiting
Soenderborg, 6400
-
Denmark
Finland
Novartis Investigative Site
Recruiting
Tampere, FIN-33521
-
Finland
Novartis Investigative Site
Recruiting
Turku, 20520
-
Finland
France
Novartis Investigative Site
Recruiting
Bron, 69677
-
France
Novartis Investigative Site
Recruiting
Cahors, 50269
-
France
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 115 25
GR
Greece
Hungary
Novartis Investigative Site
Recruiting
Gyor, H-9023
-
Hungary
Ireland
Novartis Investigative Site
Recruiting
Dublin 4, D04 T6F
-
Ireland
Italy
Novartis Investigative Site
Recruiting
Catania, 95123
CT
Italy
Novartis Investigative Site
Recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Genova, 16132
-
Italy
Novartis Investigative Site
Recruiting
Roma, 189
-
Italy
Lebanon
Novartis Investigative Site
Recruiting
Beirut, 1107 2020
-
Lebanon
Mexico
Novartis Investigative Site
Recruiting
Mexico, 05300
Distrito Federal
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam,
-
Netherlands
Norway
Novartis Investigative Site
Withdrawn
Bergen, 5021
-
Norway
Poland
Novartis Investigative Site
Recruiting
Lubin, 20-089
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02-957
-
Poland
Portugal
Novartis Investigative Site
Recruiting
Amadora, 2720-276
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 127018
-
Russian Federation
Saudi Arabia
Novartis Investigative Site
Recruiting
Jeddah, 21499
-
Saudi Arabia
Novartis Investigative Site
Recruiting
Riyadh, 11211
-
Saudi Arabia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41071
Andalucia
Spain
Sweden
Novartis Investigative Site
Recruiting
Goeteborg, 413 45
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4031
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1011
-
Switzerland
Novartis Investigative Site
Recruiting
St Gallen, 9007
-
Switzerland
United Arab Emirates
Novartis Investigative Site
Recruiting
Abu Dhabi,
-
United Arab Emirates
Novartis Investigative Site
Recruiting
Dubai,
-
United Arab Emirates
United Kingdom
Novartis Investigative Site
Recruiting
Newcastle upon Tyne, NE1 4LP
-
United Kingdom
Novartis Investigative Site
Recruiting
Norwich, NR1 3SR
-
United Kingdom
Novartis Investigative Site
Recruiting
Nottingham, NG7 2UH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]