Clinical trial NCT01285479: The Gilenya Pregnancy Registry
Official title: The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Fingolimod
FTY720
Gilenya
Multiple sclerosis
MS
Safety
Pregnancy
Pregnancy outcomes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 312
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with MS who become pregnant and were exposed to at least one dose of Gilenya during pregnancy (or up to 8 weeks before last menstrual period).

Brief 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.


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.

Primary outcomes:
measure: Frequency of major malformations associated with exposure to fingolimod during pregnancy
timeFrame: Up to 23 months
measure: Frequency of minor congenital malformations associated to fingolimod during pregnancy
timeFrame: Up to 23 months
Secondary outcomes:
measure: Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy
timeFrame: Up to 23 months
measure: Number of spontaneous abortions, stillbirths and elective terminations;
timeFrame: Up to 23 months
measure: Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age
timeFrame: Up to 23 months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Cambridge
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Grand Forks
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Bahía Blanca
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Saint-Laurent
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Nicosia
country: Cyprus
facility: Novartis Investigative Site
city: Ostrava-Poruba
country: Czechia
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Aarhus
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Soenderborg
country: Denmark
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Bron
country: France
facility: Novartis Investigative Site
city: Cahors
country: France
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Lubin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Amadora
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Goeteborg
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Norwich
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: