Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pregnancy Registry Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 26, 2011
Last updated: December 5, 2016
Last verified: December 2016

January 26, 2011
December 5, 2016
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 Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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 Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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 Identifier (NCT Number) in Medline.
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

Child, Adult, Senior
Contact: Quintiles Outcome 18775987237
Contact: Novartis Pharmaceuticals 41613241111
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Germany,   Norway,   Switzerland,   United Kingdom
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
December 2016

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