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Pregnancy Registry Trial
This study is currently recruiting participants.
Verified December 2016 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01285479
First received: January 26, 2011
Last updated: December 13, 2016
Last verified: December 2016
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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
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 |
| 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| 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
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
Show 20 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285479
Contacts
| Contact: Quintiles Outcome | 18775987237 | ||
| Contact: Novartis Pharmaceuticals | 41613241111 |
Show 20 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01285479 History of Changes |
| Other Study ID Numbers: |
CFTY720D2404 |
| Study First Received: | January 26, 2011 |
| Last Updated: | December 13, 2016 |
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 |
ClinicalTrials.gov processed this record on June 28, 2017