Pregnancy Registry Trial

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01285479
First received: January 26, 2011
Last updated: March 24, 2014
Last verified: March 2014

January 26, 2011
March 24, 2014
October 2011
August 2017   (final data collection date for primary outcome measure)
Major malformations, minor congenital anomalies & overall pregnancy outcomes will be collected; Complications during pregnancy, potential AEs on the physical & immune system development of the offspring, & any other adverse pregnancy/maternal outcomes. [ Time Frame: Throughout the entirety of a patient's participation in the study which would include 9 months of pregnancy and 1 year of follow up post pregnancy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01285479 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pregnancy Registry Trial
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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).

Multiple Sclerosis
Drug: Fingolimod
prescribed fingolimod 0.5 mg/day
Intervention: Drug: Fingolimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
August 2017
August 2017   (final data collection date for primary outcome measure)

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

Female
Not Provided
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Germany,   Norway,   Switzerland,   United Kingdom
 
NCT01285479
CFTY720D2404
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP