The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (Gilenya Pregnancy Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49237
• EU PAS number:
  EUPAS2569
• Study ID:
  49237
• Official title and acronym:
  The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (Gilenya Pregnancy Registry)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belgium

  Canada

  Cyprus

  Czechia

  Denmark

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Lebanon

  Mexico

  Netherlands

  Poland

  Portugal

  Russian Federation

  Saudi Arabia

  Spain

  Sweden

  Switzerland

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  The Gilenya Pregnancy Exposure Registry is a (at least) six-year, multi-national, prospective observational study. ; It is designed as a prospective, observational registry collecting data regarding fingolimod exposure during pregnancy and maternal, fetal and infant outcomes. ; Early and later term pregnancy outcomes will be solicited at selected gestational time points and at the estimated date of delivery. ; Structural and functional congenital anomalies identified in the perinatal period through one year of life will be collected and classified, and developmental status in infants will also be recorded. ; In order to reduce the bias that may occur when some outcome information is known prior to enrollment, women are advised to enroll in the registry as soon as their pregnancy is known, preferably in the first trimester before the condition of the fetus has been assessed through targeted prenatal testing.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 27/08/2010

Actual: 17/08/2010

Study start date

Planned: 08/03/2011

Actual: 15/10/2011

Data analysis start date

Planned: 29/02/2012

Actual: 29/05/2024

Date of interim report, if expected

Planned: 17/04/2012

Actual: 28/03/2012

Date of final study report

Planned: 31/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Study protocol

Initial protocol

CFTY720D2404-v03--protocol_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CFTY720D2404