Pregnancy Registry Trial

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01285479

First received: January 26, 2011

Last updated: December 9, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition	Intervention
Multiple Sclerosis	Drug: Fingolimod


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Multi-National Pregnancy Fingolimod Exposure Registry in Multiple Sclerosis (Epidemiological Study Protocol FTY720D2404)

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod Fingolimod hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	500
Study Start Date:	October 2011
Estimated Study Completion Date:	August 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
prescribed fingolimod 0.5 mg/day	Drug: Fingolimod

Eligibility


Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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).

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285479

Contacts


Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Show 20 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

No publications provided


Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01285479 History of Changes
Other Study ID Numbers:	CFTY720D2404
Study First Received:	January 26, 2011
Last Updated:	December 9, 2014
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Agencia Nacional de Vigilancia Sanitaria Canada: Health Canada Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Bundesinstituts für Arzneimittel und Medizinprodukte (BfArm) Greece: National Organization of Medicines Guatemala: Departamento de Regulación, y Control de Productos Farmacéuticos y Afines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Israel: Institutional Review Boards Italy: Agenzia Italiana del Formaco Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Authority of Medicines and Health Products (INFARMED) Romania: National Medicines Agency Russia: Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) - Federal State Institution Scientific Center of Assessment of Medical Products Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Switzerland: Swissmedic Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:


Fingolimod FTY720 Gilenya Multiple sclerosis	MS Safety Pregnancy Pregnancy outcomes

Additional relevant MeSH terms:


Multiple Sclerosis Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases	Nervous System Diseases Pathologic Processes Fingolimod Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015

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