The Gilenya Pregnancy Registry

January 19, 2025 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals
  • Phone Number: 1-888-669-6682

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000FAL
        • Novartis Investigative Site
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, 8000
        • Novartis Investigative Site
  • Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Linz, Austria, 4020
        • Novartis Investigative Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Saint-Laurent, Quebec, Canada, H4M-2P4
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia
        • Novartis Investigative Site
  • Cyprus
      • Nicosia, Cyprus, 1683
        • Novartis Investigative Site
  • Czechia
      • Ostrava-Poruba, Czechia, 708 52
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Novartis Investigative Site
      • Aarhus, Denmark, 8000 C
        • Novartis Investigative Site
      • Copenhagen, Denmark, DK-2100
        • Novartis Investigative Site
      • Soenderborg, Denmark, 6400
        • Novartis Investigative Site
  • Finland
      • Tampere, Finland, FIN-33521
        • Novartis Investigative Site
      • Turku, Finland, 20520
        • Novartis Investigative Site
  • France
      • Bron, France, 69677
        • Novartis Investigative Site
      • Cahors, France, 50269
        • Novartis Investigative Site
  • Germany
      • Bochum, Germany, 44791
        • Novartis Investigative Site
  • Greece
    • GR
      • Athens, GR, Greece, 115 25
        • Novartis Investigative Site
  • Hungary
      • Gyor, Hungary, H-9023
        • Novartis Investigative Site
    • HUN
      • Budapest, HUN, Hungary, 1204
        • Novartis Investigative Site
  • Ireland
      • Dublin 4, Ireland, D04 T6F
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
  • Italy
    • CT
      • Catania, CT, Italy, 95123
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 189
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italy, 10043
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 05300
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
  • Poland
      • Lubin, Poland, 20-089
        • Novartis Investigative Site
      • Warszawa, Poland, 02-957
        • Novartis Investigative Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 050098
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 127018
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21499
        • Novartis Investigative Site
      • Riyadh, Saudi Arabia, 11211
        • Novartis Investigative Site
  • Slovakia
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 811 07
        • Novartis Investigative Site
  • Slovenia
      • Maribor, Slovenia, 2000
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28222
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41071
        • Novartis Investigative Site
  • Sweden
      • Goeteborg, Sweden, 413 45
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
      • St Gallen, Switzerland, 9007
        • Novartis Investigative Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Novartis Investigative Site
      • Dubai, United Arab Emirates
        • Novartis Investigative Site
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR1 3SR
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Novartis Investigative Site
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Novartis Investigative Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
fingolimod
prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod
Drug: Fingolimod
fingolimod 0.5 mg/day, including generic versions of fingolimod

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 23 months
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.
Up to 23 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy
Time Frame: Up to 23 months
Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy would be collected
Up to 23 months
Number of spontaneous abortions, stillbirths and elective terminations;
Time Frame: Up to 23 months
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFTY720D2404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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