Multiple SclerosisNCT01285479
The Gilenya Pregnancy Registry
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 61 sites in 34 countries.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fingolimod
- How many people
- 312 participants
- Where
- 61 sitesin 34 countries
- Study dates
- 15 Oct 2011to 29 May 2024
- How long will I take part?
- 23 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- There are no specific exclusion criteria for this registry.
Trial locations and contacts
61 sites in 34 countries.
61 sites in 34 countries
Italy6 sites
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Roma, RM, 189
Denmark4 sites
Novartis Investigative Site
Aalborg, 9000
Novartis Investigative Site
Aarhus, 8000 C
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Sønderborg, 6400
Switzerland4 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Sankt Gallen, 9007
United States3 sites
Novartis Investigative Site
Cambridge, Massachusetts, 02139
Novartis Investigative Site
Fort Lauderdale, Florida, 33308
Novartis Investigative Site
Grand Forks, North Dakota, 58201
United Kingdom3 sites
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Norwich, NR1 3SR
Novartis Investigative Site
Nottingham, NG7 2UH
Argentina2 sites
Novartis Investigative Site
Bahía Blanca, Buenos Aires, 8000
Novartis Investigative Site
Córdoba, X5000FAL
Austria2 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Linz, 4020
Belgium2 sites
Novartis Investigative Site
Brasschaat, 2930
Novartis Investigative Site
Leuven, 3000
Finland2 sites
Novartis Investigative Site
Tampere, FIN-33521
Novartis Investigative Site
Turku, 20520
France2 sites
Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Cahors, 50269
Hungary2 sites
Novartis Investigative Site
Budapest, HUN, 1204
Novartis Investigative Site
Győr, H-9023
Israel2 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Ramat Gan, 52621
Poland2 sites
Novartis Investigative Site
Lubin, 20-089
Novartis Investigative Site
Warsaw, 02-957
Portugal2 sites
Novartis Investigative Site
Amadora, 2720-276
Novartis Investigative Site
Porto, 4099-001
Saudi Arabia2 sites
Novartis Investigative Site
Jeddah, 21499
Novartis Investigative Site
Riyadh, 11211
Spain2 sites
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Seville, Andalusia, 41071
United Arab Emirates2 sites
Novartis Investigative Site
Abu Dhabi
Novartis Investigative Site
Dubai
Brazil1 site
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913
Slovakia1 site
Novartis Investigative Site
Bratislava, Slovak Republic, 811 07
About this study
Official title: The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Fingolimod
- Keywords
- Fingolimod, FTY720, Gilenya, Multiple sclerosis, MS, Safety, Pregnancy, Pregnancy outcomes
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
fingolimod 0.5 mg/day, including generic versions of fingolimod
| Study group | Role | What they receive |
|---|---|---|
| fingolimod | prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod Receives: Drug: Fingolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 23 months
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.
Measured: Up to 23 months
Secondary outcomes (3)
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
Measured: Up to 23 months
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
Measured: Up to 23 months
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
Measured: Up to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study start15 Oct 2011
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
- Target duration
- 23 Months
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285479
- Sponsor's protocol ID
- CFTY720D2404
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2011
- Last updated
- 22 Jan 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01285479
- Acronym / sponsor ID
- CFTY720D2404
- Conditions
- Multiple Sclerosis
- Keywords
- Fingolimod, FTY720, Gilenya, Multiple sclerosis, MS, Safety, Pregnancy, Pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2011 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 23 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fingolimod | – | Drug: Fingolimodprescribed fingolimod 0.5 mg/day, including generic versions of fingolimod |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingolimodfingolimod 0.5 mg/day, including generic versions of fingolimod | Drug | fingolimod |
Primary outcome
Frequency of major malformations associated with exposure to fingolimod during pregnancy
Time frame: Up to 23 months
Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.
Frequency of minor congenital malformations associated to fingolimod during pregnancy
Time frame: Up to 23 months
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.
3 secondary outcomes
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy
Time frame: Up to 23 months
Number of spontaneous abortions, stillbirths and elective terminations;
Time frame: Up to 23 months
Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age
Time frame: Up to 23 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- https://www.gilenyapregnancyregistry.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
61 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 61 sites in 34 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Italy, Denmark, Switzerland, United States, United Kingdom and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of major malformations associated with exposure to fingolimod during pregnancy (time frame: Up to 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.