The Gilenya Pregnancy Registry

March 13, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

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

  • Name: Novartis Pharmaceuticals
  • Phone Number: 1-888-669-6682

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000FAL
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, 8000
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Novartis Investigative Site
      • Linz, Austria, 4020
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • Recruiting
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
      • Melsbroek, Belgium, 1820
        • Withdrawn
        • Novartis Investigative Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Saint-Laurent, Quebec, Canada, H4M-2P4
        • Recruiting
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia
        • Recruiting
        • Novartis Investigative Site
  • Cyprus
      • Nicosia, Cyprus, 1683
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Ostrava-Poruba, Czechia, 708 52
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Novartis Investigative Site
      • Aarhus, Denmark, 8000 C
        • Recruiting
        • Novartis Investigative Site
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Novartis Investigative Site
      • Soenderborg, Denmark, 6400
        • Recruiting
        • Novartis Investigative Site
  • Finland
      • Tampere, Finland, FIN-33521
        • Recruiting
        • Novartis Investigative Site
      • Turku, Finland, 20520
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bron, France, 69677
        • Recruiting
        • Novartis Investigative Site
      • Cahors, France, 50269
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Bochum, Germany, 44791
        • Recruiting
        • Novartis Investigative Site
  • Greece
    • GR
      • Athens, GR, Greece, 115 25
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Gyor, Hungary, H-9023
        • Recruiting
        • Novartis Investigative Site
    • HUN
      • Budapest, HUN, Hungary, 1204
        • Recruiting
        • Novartis Investigative Site
  • Ireland
      • Dublin 4, Ireland, D04 T6F
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • CT
      • Catania, CT, Italy, 95123
        • Recruiting
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Recruiting
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 189
        • Recruiting
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italy, 10043
        • Recruiting
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • Recruiting
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 05300
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, 5021
        • Withdrawn
        • Novartis Investigative Site
  • Poland
      • Lubin, Poland, 20-089
        • Recruiting
        • Novartis Investigative Site
      • Warszawa, Poland, 02-957
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 050098
        • Recruiting
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 127018
        • Recruiting
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21499
        • Recruiting
        • Novartis Investigative Site
      • Riyadh, Saudi Arabia, 11211
        • Recruiting
        • Novartis Investigative Site
    • SAU
      • Riyadh, SAU, Saudi Arabia, 11525
        • Withdrawn
        • Novartis Investigative Site
  • Slovakia
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 811 07
        • Recruiting
        • Novartis Investigative Site
  • Slovenia
      • Maribor, Slovenia, 2000
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28222
        • Recruiting
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41071
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Goeteborg, Sweden, 413 45
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
      • St Gallen, Switzerland, 9007
        • Recruiting
        • Novartis Investigative Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Dubai, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR1 3SR
        • Recruiting
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Novartis Investigative Site
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Recruiting
        • Novartis Investigative Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • 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

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
Intervention / Treatment
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

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

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

Novartis Pharmaceuticals

Investigators

  • 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)

October 15, 2011

Primary Completion (Estimated)

January 2, 2031

Study Completion (Estimated)

January 2, 2031

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimated)

January 28, 2011

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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