Last Update: Mar 15, 2024
The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis
ClinicalTrials.gov Identifier:
NCT01285479
Novartis Reference Number:CFTY720D2404
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Multiple Sclerosis
Recruiting
500
Oct 15, 2011
Jan 02, 2031
Female
- (Child, Adult, Older Adult)

Interventions

Drug

Fingolimod

fingolimod 0.5 mg/day, including generic versions of fingolimod

Eligibility Criteria

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.

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Novartis Pharmaceuticals

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1-888-669-6682