Pregnancy Registry Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01285479
Recruitment Status : Recruiting
First Posted : January 28, 2011
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

January 26, 2011
January 28, 2011
August 1, 2017
October 15, 2011
September 25, 2023   (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 ]
Same as current
Complete list of historical versions of study NCT01285479 on Archive Site
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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.
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 25, 2023
September 25, 2023   (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

Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
Argentina,   Australia,   Belgium,   Canada,   Cyprus,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Ireland,   Italy,   Lebanon,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Spain,   Sweden,   Switzerland,   United Arab Emirates,   United Kingdom,   United States
Austria,   Czech Republic,   Norway
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
July 2017