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Completed

NCT Number: NCT01285479

The Gilenya Pregnancy Registry

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Novartis Investigative Site, Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fingolimod

Drug

fingolimod 0.5 mg/day, including generic versions of fingolimod

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2011
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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