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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01285479




Registration number
NCT01285479
Ethics application status
Date submitted
26/01/2011
Date registered
28/01/2011
Date last updated
15/03/2024

Titles & IDs
Public title
The Gilenya Pregnancy Registry
Scientific title
The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
Secondary ID [1] 0 0
CFTY720D2404
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod

fingolimod - prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod


Treatment: Drugs: Fingolimod
fingolimod 0.5 mg/day, including generic versions of fingolimod
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of major malformations associated with exposure to fingolimod during pregnancy
Timepoint [1] 0 0
Up to 23 months
Primary outcome [2] 0 0
Frequency of minor congenital malformations associated to fingolimod during pregnancy
Timepoint [2] 0 0
Up to 23 months
Secondary outcome [1] 0 0
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy
Timepoint [1] 0 0
Up to 23 months
Secondary outcome [2] 0 0
Number of spontaneous abortions, stillbirths and elective terminations;
Timepoint [2] 0 0
Up to 23 months
Secondary outcome [3] 0 0
Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age
Timepoint [3] 0 0
Up to 23 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* There are no specific exclusion criteria for this registry.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/01/2031
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
North Dakota
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Austria
State/province [6] 0 0
Graz
Country [7] 0 0
Austria
State/province [7] 0 0
Linz
Country [8] 0 0
Belgium
State/province [8] 0 0
Brasschaat
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Melsbroek
Country [11] 0 0
Brazil
State/province [11] 0 0
RJ
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Colombia
State/province [13] 0 0
Bogotá
Country [14] 0 0
Cyprus
State/province [14] 0 0
Nicosia
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava-Poruba
Country [16] 0 0
Denmark
State/province [16] 0 0
Aalborg
Country [17] 0 0
Denmark
State/province [17] 0 0
Aarhus
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen
Country [19] 0 0
Denmark
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Soenderborg
Country [20] 0 0
Finland
State/province [20] 0 0
Tampere
Country [21] 0 0
Finland
State/province [21] 0 0
Turku
Country [22] 0 0
France
State/province [22] 0 0
Bron
Country [23] 0 0
France
State/province [23] 0 0
Cahors
Country [24] 0 0
Germany
State/province [24] 0 0
Bochum
Country [25] 0 0
Greece
State/province [25] 0 0
GR
Country [26] 0 0
Hungary
State/province [26] 0 0
HUN
Country [27] 0 0
Hungary
State/province [27] 0 0
Gyor
Country [28] 0 0
Ireland
State/province [28] 0 0
Dublin 4
Country [29] 0 0
Israel
State/province [29] 0 0
Jerusalem
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat Gan
Country [31] 0 0
Italy
State/province [31] 0 0
CT
Country [32] 0 0
Italy
State/province [32] 0 0
FI
Country [33] 0 0
Italy
State/province [33] 0 0
GE
Country [34] 0 0
Italy
State/province [34] 0 0
MI
Country [35] 0 0
Italy
State/province [35] 0 0
RM
Country [36] 0 0
Italy
State/province [36] 0 0
TO
Country [37] 0 0
Lebanon
State/province [37] 0 0
Beirut
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Mexico
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Distrito Federal
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Netherlands
State/province [39] 0 0
Amsterdam
Country [40] 0 0
Norway
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Bergen
Country [41] 0 0
Poland
State/province [41] 0 0
Lubin
Country [42] 0 0
Poland
State/province [42] 0 0
Warszawa
Country [43] 0 0
Portugal
State/province [43] 0 0
Amadora
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Romania
State/province [45] 0 0
Bucharest
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Saudi Arabia
State/province [47] 0 0
SAU
Country [48] 0 0
Saudi Arabia
State/province [48] 0 0
Jeddah
Country [49] 0 0
Saudi Arabia
State/province [49] 0 0
Riyadh
Country [50] 0 0
Slovakia
State/province [50] 0 0
Slovak Republic
Country [51] 0 0
Slovenia
State/province [51] 0 0
Maribor
Country [52] 0 0
Spain
State/province [52] 0 0
Andalucia
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Sweden
State/province [54] 0 0
Goeteborg
Country [55] 0 0
Switzerland
State/province [55] 0 0
Basel
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bern
Country [57] 0 0
Switzerland
State/province [57] 0 0
Lausanne
Country [58] 0 0
Switzerland
State/province [58] 0 0
St Gallen
Country [59] 0 0
United Arab Emirates
State/province [59] 0 0
Abu Dhabi
Country [60] 0 0
United Arab Emirates
State/province [60] 0 0
Dubai
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Newcastle upon Tyne
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Norwich
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01285479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01285479