Pregnancy Registry Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/10/2019 |
| Start Date: | October 15, 2011 |
| End Date: | December 13, 2030 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
The Multi-National Pregnancy Fingolimod Exposure Registry in Multiple Sclerosis (Epidemiological Study Protocol FTY720D2404)
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 Gilenya before (up to 8 weeks before last menstrual
period) 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.
(MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects
in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual
period) 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.
Inclusion Criteria:
- Pregnancy and reported confirmed or suspected maternal exposure to Gilenya any time
during pregnancy or shortly before pregnancy (up to 8 weeks before LMP).
- Informed consent
Exclusion Criteria:
- There are no specific exclusion criteria for this registry.
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
4
sites
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