Pregnancy Registry Trial
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ClinicalTrials.gov Identifier: NCT01285479 |
Recruitment Status
:
Recruiting
First Posted
: January 28, 2011
Last Update Posted
: August 1, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis | Drug: Fingolimod |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Multi-National Pregnancy Fingolimod Exposure Registry in Multiple Sclerosis (Epidemiological Study Protocol FTY720D2404) |
Actual Study Start Date : | October 15, 2011 |
Estimated Primary Completion Date : | September 25, 2023 |
Estimated Study Completion Date : | September 25, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
prescribed fingolimod 0.5 mg/day | Drug: Fingolimod |
- 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 ]

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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 |
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

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

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01285479 History of Changes |
Other Study ID Numbers: |
CFTY720D2404 |
First Posted: | January 28, 2011 Key Record Dates |
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 |