Pregnancy Registry Trial

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by Novartis ( Novartis Pharmaceuticals )

Sponsor:

ClinicalTrials.gov Identifier:

NCT01285479

First Posted: January 28, 2011

Last Update Posted: August 1, 2017

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.

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

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 ( Novartis Pharmaceuticals ):

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 ]


Estimated Enrollment:	500
Actual Study Start Date:	October 15, 2011
Estimated Study Completion Date:	September 25, 2023
Estimated Primary Completion Date:	September 25, 2023 (Final data collection date for primary outcome measure)

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285479

Contacts


Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals	+41613241111

Show 41 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Additional Information:

https://www.gilenyapregnancyregistry.com This link exits the ClinicalTrials.gov site


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01285479 History of Changes
Other Study ID Numbers:	CFTY720D2404
First Submitted:	January 26, 2011
First Posted:	January 28, 2011
Last Update Posted:	August 1, 2017
Last Verified:	July 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Fingolimod FTY720 Gilenya Multiple sclerosis	MS Safety Pregnancy Pregnancy outcomes

Additional relevant MeSH terms:


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

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