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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

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
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Soenderborg
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Finland
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Tampere
Country [21] 0 0
Finland
State/province [21] 0 0
Turku
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France
State/province [22] 0 0
Bron
Country [23] 0 0
France
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Cahors
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Germany
State/province [24] 0 0
Bochum
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Greece
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GR
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Hungary
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HUN
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Hungary
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Gyor
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Ireland
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Dublin 4
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Italy
State/province [31] 0 0
CT
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Italy
State/province [32] 0 0
FI
Country [33] 0 0
Italy
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GE
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Italy
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MI
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Italy
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RM
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Italy
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TO
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Lebanon
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Beirut
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Mexico
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Distrito Federal
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Netherlands
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Amsterdam
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Norway
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Bergen
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Poland
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Lubin
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Poland
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Warszawa
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Portugal
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Amadora
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Portugal
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Porto
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Romania
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Bucharest
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Russian Federation
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Moscow
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Saudi Arabia
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SAU
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Saudi Arabia
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Jeddah
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Saudi Arabia
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Riyadh
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Slovakia
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Slovak Republic
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Slovenia
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Maribor
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Spain
State/province [52] 0 0
Andalucia
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Spain
State/province [53] 0 0
Madrid
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Sweden
State/province [54] 0 0
Goeteborg
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01285479