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Pregnancy Registry Trial

This study is currently recruiting participants.
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:


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

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, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
United States, Florida
Novartis Investigative Site Recruiting
Fort Lauderdale, Florida, United States, 33308
United States, Massachusetts
Novartis Investigative Site Recruiting
Cambridge, Massachusetts, United States, 02139
Argentina
Novartis Investigative Site Recruiting
Cordoba, Argentina, X5000FAL
Australia, Victoria
Novartis Investigative Site Recruiting
Box Hill, Victoria, Australia, 3128
Belgium
Novartis Investigative Site Recruiting
Brasschaat, Belgium, 2930
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Canada, Quebec
Novartis Investigative Site Recruiting
Saint-Laurent, Quebec, Canada, H4M-2P4
Cyprus
Novartis Investigative Site Recruiting
Nicosia, Cyprus, 1683
Czechia
Novartis Investigative Site Recruiting
Ostrava-Poruba, Czechia, 708 52
Denmark
Novartis Investigative Site Recruiting
Aarhus, Denmark, 8000 C
Novartis Investigative Site Recruiting
Copenhagen, Denmark, DK-2100
Novartis Investigative Site Recruiting
Soenderborg, Denmark, 6400
Finland
Novartis Investigative Site Recruiting
Tampere, Finland, FIN-33521
Novartis Investigative Site Recruiting
Turku, Finland, 20520
France
Novartis Investigative Site Recruiting
Cahors, France, 50269
Germany
Novartis Investigative Site Recruiting
Bochum, Germany, 44791
Greece
Novartis Investigative Site Recruiting
Athens, GR, Greece, 115 25
Ireland
Novartis Investigative Site Recruiting
Dublin 4, Ireland
Italy
Novartis Investigative Site Recruiting
Catania, CT, Italy, 95123
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50134
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Recruiting
Genova, Italy, 16132
Novartis Investigative Site Recruiting
Roma, Italy, 189
Lebanon
Novartis Investigative Site Recruiting
Beirut, Lebanon, 1107 2020
Mexico
Novartis Investigative Site Recruiting
Mexico, Distrito Federal, Mexico, 05300
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands
Poland
Novartis Investigative Site Recruiting
Lubin, Poland, 20-089
Novartis Investigative Site Recruiting
Warszawa, Poland, 02-957
Portugal
Novartis Investigative Site Recruiting
Amadora, Portugal, 2720-276
Russian Federation
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 127018
Saudi Arabia
Novartis Investigative Site Recruiting
Jeddah, Saudi Arabia, 21499
Novartis Investigative Site Recruiting
Riyadh, Saudi Arabia, 11211
Spain
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41071
Sweden
Novartis Investigative Site Recruiting
Goeteborg, Sweden, 413 45
Switzerland
Novartis Investigative Site Recruiting
Basel, Switzerland, 4031
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Recruiting
St. Gallen, Switzerland, 9007
United Arab Emirates
Novartis Investigative Site Recruiting
Dubai, United Arab Emirates
United Kingdom
Novartis Investigative Site Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Novartis Investigative Site Recruiting
Norwich, United Kingdom, NR1 3SR
Novartis Investigative Site Recruiting
Nottingham, United Kingdom, NG7 2UH
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
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