|
|
About the Registry
Fingolimod has not been studied in pregnant women in clinical trials and therefore data are too limited to draw conclusions on safety of fingolimod on pregnancy and pregnancy outcome.
In animal studies, fingolimod has shown reproductive toxicity. The use of fingolimod in women who are or may become pregnant should only be considered if the potential benefit justifies the potential risk to fetus. In pre-clinical experiments fingolimod was found to be excreted in milk of treated animals during lactation. Because of the potential for serious adverse drug reactions in nursing infants, women receiving fingolimod should not breast feed.
For more information on the use of fingolimod during pregnancy and breastfeeding, Healthcare Professionals should refer to the product label in their country.
Objectives of the registry
The overall goal of the GILENYA pregnancy exposure registry is to prospectively collect and evaluate safety data on fingolimod exposure immediately before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy. Information collected in this registry will be used to compare the maternal, fetal, and infant outcomes in the registry with background frequency of events from reference populations. Safety information received from the registry will be shared with health authorities; however individual personally identifiable information will not be revealed in such disclosures without permission.
Importance of your participation in the study
Pregnant women should be enrolled as early as possible, in order to provide sufficient data for robust analysis. This analysis will be used to better understand the risk of adverse outcomes for mothers, fetuses and/or newborn children and contribute to improve their treatment/medical management.
Registry Design
The registry is designed as a voluntary at least six-year multi-national prospective observational registry that aims to enroll up to 500 pregnant women that have taken fingolimod. Women will be followed up at baseline, mid 2nd trimester (21 weeks gestational age +/-2 weeks), post-partum, and 3 month and 1 year follow-up of the infant. Only pregnant women who have taken fingolimod at any time during their pregnancy or up to 8 weeks before Last Menstrual Period (LMP) are eligible to enroll.
In view of the fact that eligible patients may be located at various geographical locations, several National Coordinating Sites (NCS) per country have been established. Any physician, who has identified an eligible patient, is encouraged to participate in the registry as a Sentinel Site. The Sentinel Sites will be responsible to enroll subjects at their site and provide data. If the physician prefers, the patient can also be referred to a National Coordinating Site.
Quintiles Outcome will support flexible data collection through either paper CRF, web-based electronic CRF or telephone. The web based application supporting the data collection does not require any software to be installed onto your computer.
Inclusion Criteria
Patients eligible for enrollment in this study must fulfill the following criteria:
- Any pregnant female who has reported either confirmed or suspected exposure to fingolimod at any time during pregnancy or up to 8 weeks before Last Menstrual Period (LMP).
- Patient Informed consent has been obtained.
How to use the Electronic Data Capture tool
Data collected by the sites will be entered using an electronic data capture (EDC) system via electronic case report forms (eCRFs). This is a web based application that is easily accessed via this website and does not require any software to be installed onto your computer.
Once you have registered yourself as a sentinel site, you will be provided with the registry start-up pack, which will include amongst other documents:
- Patient Informed Consent Forms (ICF)
- Registry protocol
- Safety reporting procedures
- Username and password for the Electronic Data Capture system
Please note patients must have signed the Informed Consent Form before any data can be entered into the registry.
How to join the registry
If you are interested in the registry, do not hesitate to contact us.
Once you have registered yourself as a Sentinel Site, you will be provided with the registry start-up pack, which will include amongst other documents:
- Patient Informed Consent Forms (ICF)
- Registry protocol
- Safety reporting procedures
- Username and password for the Electronic Data Capture system
Please note that your patients must have signed the Informed Consent Form before any data can be collected and/or entered into the registry eCRFs.
|
How to Enroll a Patient
To enroll a patient in the registry, please complete and return the registration form (see details below).
You will be contacted by Quintiles Outcome, the research organization managing the registry and provided with all necessary information to be able to participate in the registry. Patient data can only be entered once they have signed the Informed Consent Form.
You can complete the registration process by either filling in the online form or by calling, emailing or writing to Quintiles Outcome.
Phone:
US:
1-877-598-7237 (toll-free)
Canada:
1-855-788-5333 (toll-free)
Other Countries:
+800 688 266 37 (toll-free)
Email: gpr@quintiles.com/ gpr@IQVIA.com or
Post address:
GILENYA Pregnancy Registry
Quintiles Outcome Europe
Chemin du Glapin 6
1162 St Prex, Switzerland
Online Submission:
Complete the registration form directly and click "submit" to send to Quintiles Outcome.
|
