Pregnancy Registry Trial

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 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.

Study Start Date

October 2011

Estimated Completion Date

August 2017

Interventions

  • Drug: Fingolimod
  • Other: fingolimod

Specialties

  • Obstetrics & Gynecology: Obstetrics,Preventive Medicine
  • Neurology: Demyelinating Disorders,Neuro/Psych pharmacology

MeSH Terms

  • Fingolimod
  • Multiple Sclerosis
  • Sclerosis

Study ID

Novartis -- CFTY720D2404

Status

Unknown

Trial ID

NCT01285479

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

500

Sponsor

Novartis

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

Gender

Female

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Novartis Investigative Site - Cambridge, Massachusetts 2.0 miles None None None
Novartis Investigative Site - Voorhees, New Jersey 266.6 miles None None None
Novartis Investigative Site - Grand Forks, North Dakota 1,317.8 miles None None None
Novartis Investigative Site - Grand Forks, North Dakota 1,317.8 miles None None None
Novartis Investigative Site - Round Rock, Texas 1,684.7 miles None None None
Novartis Investigative Site - Round Rock, Texas 1,684.7 miles None None None

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