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NCT01285479 · ClinicalTrials.gov registry record
The Gilenya Pregnancy Registry
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 312
- Enrollment target
NCT01285479: Completed study, sponsored by Novartis Pharmaceuticals.
NCT01285479 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 312 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285479 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 312 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.
Interventions
- DRUG Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2011-10-15 |
| Est. Completion | 2024-05-29 |
What the finished NCT01285479 record still lists
NCT01285479 is an observational study that tracks outcomes without assigning an intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Fingolimod is the first listed.
NCT01285479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285479 about?
NCT01285479 is a clinical study titled "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 duri...
What is the current status of trial NCT01285479?
This trial is currently completed. The enrollment target is 312 participants. The study started on 2011-10-15. Estimated completion is 2024-05-29.
What interventions are being tested in trial NCT01285479?
The interventions under investigation include: Fingolimod (DRUG).
Who is sponsoring clinical trial NCT01285479?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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