The Gilenya Pregnancy Registry

NCT01285479 | Completed

• 1 other identifier: CFTY720D2404
• Study Type: observational
• Target: 312
• Locations: 32 countries
• Sites: 58

Brief Summary

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 fingolimod before (up to 8 weeks before last menstrual period (LMP)) 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.

Conditions

Multiple Sclerosis

Keywords

Fingolimod; FTY720; Gilenya; Multiple sclerosis; MS; Safety; Pregnancy; Pregnancy outcomes

Outcome Measures

Primary Outcomes (2)

• Frequency of major malformations associated with exposure to fingolimod during pregnancy

  Major malformations are defined as any structural defect with surgical, medical, or cosmetic importance recognized.

  Up to 23 months

• Frequency of minor congenital malformations associated to fingolimod during pregnancy

  Minor congenital malformations: * Minor anomalies, i.e., anomalies with no serious medical or cosmetic consequence to the child. * Positional deformities, i.e., a positional deformity that usually normalizes spontaneously after about 3 months of age, e.g., abnormal head shape, torticollis. * Features of pre-maturity. * Chromosome abnormalities. * Genetic disorders.

  Up to 23 months

Secondary Outcomes (3)

• Frequency of specific types of major and minor congenital malformations associated with exposure to fingolimod during pregnancy

  Up to 23 months

• Number of spontaneous abortions, stillbirths and elective terminations;

  Up to 23 months

• Number of occurrence of physical developmental delays as well as adverse effects on immune system development in infants around one year of age

  Up to 23 months

Study Arms (1)

fingolimod

prescribed fingolimod 0.5 mg/day, including generic versions of fingolimod

Drug: Fingolimod

Interventions

Fingolimod DRUG

fingolimod 0.5 mg/day, including generic versions of fingolimod

fingolimod

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Any woman with a diagnosis of MS
• Any woman currently pregnant
• Exposure to fingolimod during pregnancy or up to 8 weeks before LMP
• Signed informed consent

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (61)

Novartis Investigative Site

Fort Lauderdale, Florida, 33308, United States

Location

Novartis Investigative Site

Cambridge, Massachusetts, 02139, United States

Location

Novartis Investigative Site

Grand Forks, North Dakota, 58201, United States

Location

Novartis Investigative Site

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Novartis Investigative Site

Córdoba, X5000FAL, Argentina

Location

Novartis Investigative Site

Box Hill, Victoria, 3128, Australia

Location

Novartis Investigative Site

Graz, 8036, Austria

Location

Novartis Investigative Site

Linz, 4020, Austria

Location

Novartis Investigative Site

Brasschaat, 2930, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Novartis Investigative Site

Saint-Laurent, Quebec, H4M-2P4, Canada

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Nicosia, 1683, Cyprus

Location

Novartis Investigative Site

Ostrava-Poruba, 708 52, Czechia

Location

Novartis Investigative Site

Aalborg, 9000, Denmark

Location

Novartis Investigative Site

Aarhus, 8000 C, Denmark

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Sønderborg, 6400, Denmark

Location

Novartis Investigative Site

Tampere, FIN-33521, Finland

Location

Novartis Investigative Site

Turku, 20520, Finland

Location

Novartis Investigative Site

Bron, 69677, France

Location

Novartis Investigative Site

Cahors, 50269, France

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Athens, GR, 115 25, Greece

Location

Novartis Investigative Site

Budapest, HUN, 1204, Hungary

Location

Novartis Investigative Site

Győr, H-9023, Hungary

Location

Novartis Investigative Site

Dublin, D04 T6F, Ireland

Location

Novartis Investigative Site

Jerusalem, 9112001, Israel

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Catania, CT, 95123, Italy

Location

Novartis Investigative Site

Florence, FI, 50134, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Roma, RM, 189, Italy

Location

Novartis Investigative Site

Orbassano, TO, 10043, Italy

Location

Novartis Investigative Site

Beirut, 1107 2020, Lebanon

Location

Novartis Investigative Site

Mexico City, Mexico City, 05300, Mexico

Location

Novartis Investigative Site

Amsterdam, Netherlands

Location

Novartis Investigative Site

Lubin, 20-089, Poland

Location

Novartis Investigative Site

Warsaw, 02-957, Poland

Location

Novartis Investigative Site

Amadora, 2720-276, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Bucharest, 050098, Romania

Location

Novartis Investigative Site

Moscow, 127018, Russia

Location

Novartis Investigative Site

Jeddah, 21499, Saudi Arabia

Location

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

Location

Novartis Investigative Site

Bratislava, Slovak Republic, 811 07, Slovakia

Location

Novartis Investigative Site

Maribor, 2000, Slovenia

Location

Novartis Investigative Site

Seville, Andalusia, 41071, Spain

Location

Novartis Investigative Site

Madrid, 28222, Spain

Location

Novartis Investigative Site

Gothenburg, 413 45, Sweden

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Location

Novartis Investigative Site

Dubai, United Arab Emirates

Location

Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Novartis Investigative Site

Norwich, NR1 3SR, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

• https://www.gilenyapregnancyregistry.com

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 23 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 28, 2011
• Study Start: October 15, 2011
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); DK (4); PT (2); CZ (1); PL (2); AU (1); LE (1); US (3); IT (6); CH (4); AR (2); IL (2); SA (2); GR (1); ME (1); SE (1); ES (2); BR (1); CY (1); SL (1); CA (1); FI (2); DE (1); IE (1); RU (1); AE (2); GB (3); BE (2); FR (2); HU (2); CO (1); NL (1)