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NCT01285479 Clinical Trial

The Gilenya Pregnancy Registry

Multiple Sclerosis Clinical Trial

Official title:
The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01285479
Other study ID # CFTY720D2404
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2011
Est. completion date January 2, 2031

Study information
Verified date March 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 2, 2031
Est. primary completion date January 2, 2031
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fingolimod
fingolimod 0.5 mg/day, including generic versions of fingolimod

Locations
Country Name City State
Argentina Novartis Investigative Site Bahía Blanca Buenos Aires
Argentina Novartis Investigative Site Cordoba
Australia Novartis Investigative Site Box Hill Victoria
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Linz
Belgium Novartis Investigative Site Brasschaat
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Melsbroek
Brazil Novartis Investigative Site Rio de Janeiro RJ
Canada Novartis Investigative Site Saint-Laurent Quebec
Colombia Novartis Investigative Site Bogotá
Cyprus Novartis Investigative Site Nicosia
Czechia Novartis Investigative Site Ostrava-Poruba
Denmark Novartis Investigative Site Aalborg
Denmark Novartis Investigative Site Aarhus
Denmark Novartis Investigative Site Copenhagen
Denmark Novartis Investigative Site Soenderborg
Finland Novartis Investigative Site Tampere
Finland Novartis Investigative Site Turku
France Novartis Investigative Site Bron
France Novartis Investigative Site Cahors
Germany Novartis Investigative Site Bochum
Greece Novartis Investigative Site Athens GR
Hungary Novartis Investigative Site Budapest HUN
Hungary Novartis Investigative Site Gyor
Ireland Novartis Investigative Site Dublin 4
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Ramat Gan
Italy Novartis Investigative Site Catania CT
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Orbassano TO
Italy Novartis Investigative Site Roma RM
Lebanon Novartis Investigative Site Beirut
Mexico Novartis Investigative Site Mexico Distrito Federal
Netherlands Novartis Investigative Site Amsterdam
Norway Novartis Investigative Site Bergen
Poland Novartis Investigative Site Lubin
Poland Novartis Investigative Site Warszawa
Portugal Novartis Investigative Site Amadora
Portugal Novartis Investigative Site Porto
Romania Novartis Investigative Site Bucharest
Russian Federation Novartis Investigative Site Moscow
Saudi Arabia Novartis Investigative Site Jeddah
Saudi Arabia Novartis Investigative Site Riyadh
Saudi Arabia Novartis Investigative Site Riyadh SAU
Slovakia Novartis Investigative Site Bratislava Slovak Republic
Slovenia Novartis Investigative Site Maribor
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Sevilla Andalucia
Sweden Novartis Investigative Site Goeteborg
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Lausanne
Switzerland Novartis Investigative Site St Gallen
United Arab Emirates Novartis Investigative Site Abu Dhabi
United Arab Emirates Novartis Investigative Site Dubai
United Kingdom Novartis Investigative Site Newcastle upon Tyne
United Kingdom Novartis Investigative Site Norwich
United Kingdom Novartis Investigative Site Nottingham
United States Novartis Investigative Site Cambridge Massachusetts
United States Novartis Investigative Site Fort Lauderdale Florida
United States Novartis Investigative Site Grand Forks North Dakota

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Cyprus,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Lebanon,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of major malformations associated with exposure to fingolimod during pregnancy Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized. Up to 23 months
Primary Frequency of minor congenital malformations associated to fingolimod during pregnancy Minor congenital malformations:
Minor anomalies, i.e., anomalies with no serious medical or cosmetic consequence to the child.
Positional deformities, i.e., a positional deformity that usually normalizes spontaneously after about 3 months of age, e.g., abnormal head shape, torticollis.
Features of pre-maturity.
Chromosome abnormalities.
Genetic disorders.		 Up to 23 months
Secondary Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected Up to 23 months
Secondary Number of spontaneous abortions, stillbirths and elective terminations; Number of spontaneous abortions, stillbirths and elective terminations will be collected to characterize the nature of pregnancy and other fetal outcomes associated with exposure to fingolimod during pregnancy Up to 23 months
Secondary Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age associated with exposure to fingolimod during pregnancy Up to 23 months
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