The Gilenya Pregnancy Registry

Last updated: January 19, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Fingolimod

Clinical Study ID

NCT01285479
CFTY720D2404
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • There are no specific exclusion criteria for this registry.

Study Design

Total Participants: 312
Treatment Group(s): 1
Primary Treatment: Fingolimod
Phase:
Study Start date:
October 15, 2011
Estimated Completion Date:
May 29, 2024

Connect with a study center

  • Novartis Investigative Site

    Bahía Blanca, Buenos Aires 8000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Cordoba, X5000FAL
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Novartis Investigative Site

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bedford, 5042
    Australia

    Site Not Available

  • Novartis Investigative Site

    Camperdown, NSW 2050
    Australia

    Site Not Available

  • Novartis Investigative Site

    Hobart, 7000
    Australia

    Site Not Available

  • Novartis Investigative Site

    Subiaco, 6008
    Australia

    Site Not Available

  • Novartis Investigative Site

    Graz, 8036
    Austria

    Site Not Available

  • Novartis Investigative Site

    Linz, 4020
    Austria

    Site Not Available

  • Novartis Investigative Site

    Brasschaat, 2930
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Melsbroek, 1820
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Rio de Janeiro, RJ 21941-913
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Saint-Laurent, Quebec H4M-2P4
    Canada

    Site Not Available

  • Multiple Sclerosis Clinic

    Calgary, T2N 2T9
    Canada

    Site Not Available

  • MS Clinic

    Charny, G6X 0A1
    Canada

    Site Not Available

  • MS Clinic

    Edmonton, T6G 2G3
    Canada

    Site Not Available

  • Estrie MS Clinic

    Fleurimont, J1H 5N4
    Canada

    Site Not Available

  • Clinique Neuro-Outaouais

    Gatineau, J9J 0A5
    Canada

    Site Not Available

  • Neuro Rive-Sud MS Clinic

    Greenfield Park, J4V 2J2
    Canada

    Site Not Available

  • Multiple Sclerosis Research Unit - Dalhousie

    Halifax, B3H 4K4
    Canada

    Site Not Available

  • Hamilton MS Clinic, Hamilton Health Sciences

    Hamilton, L8N 3Z5
    Canada

    Site Not Available

  • Satellite Clinic of UBC

    Kelowna, V1Y 1T2
    Canada

    Site Not Available

  • Kingston MS Clinic

    Kingston, K7L 2V7
    Canada

    Site Not Available

  • London MS Clinic

    London, N6A 5A5
    Canada

    Site Not Available

  • Montreal Neurological Institute

    Montreal, H3A 2B4
    Canada

    Site Not Available

  • Hospital Notre-Dame - CHUM

    Montréal, H2L 4M1
    Canada

    Site Not Available

  • MS Research Clinic

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • Satellite Clinic of UBC, MS Clinic Prince George

    Prince George, V2M 1S0
    Canada

    Site Not Available

  • Clinique de maladies neuromusculaires et de sclérose en plaques IRDPQ

    Quebec, G1M 2S8
    Canada

    Site Not Available

  • Multiple Sclerosis Clinic

    Red Deer, T4N 4E7
    Canada

    Site Not Available

  • Saskatoon City Hospital

    Saskatoon, S7K 0M7
    Canada

    Site Not Available

  • MS Clinic, Division of Neurology

    St. John's, Newfoundland and Labrador, A1B 3V6
    Canada

    Site Not Available

  • Thunder Bay MS Clinic

    Thunder Bay, P7B 5G7
    Canada

    Site Not Available

  • MS Clinic

    Toronto, M5B 1W8
    Canada

    Site Not Available

  • Clinique de SP, Mauricie-Bois-Francs/CÅ“ur du Québec

    Trois-Rivières, G8Z 3R9
    Canada

    Site Not Available

  • MS Clinic

    Vancouver, V6T 2B5
    Canada

    Site Not Available

  • Vancouver Island MS Clinic

    Victoria, V8R 1J8
    Canada

    Site Not Available

  • MS Clinic

    Winnipeg, R3A 1R9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Bogotá,
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Nicosia, 1683
    Cyprus

    Site Not Available

  • Novartis Investigative Site

    Ostrava-Poruba, 708 52
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Aalborg, 9000
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Aarhus, 8000 C
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Soenderborg, 6400
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Tampere, FIN-33521
    Finland

    Site Not Available

  • Novartis Investigative Site

    Turku, 20520
    Finland

    Site Not Available

  • Novartis Investigative Site

    Bron, 69677
    France

    Site Not Available

  • Novartis Investigative Site

    Cahors, 50269
    France

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Athens, GR 115 25
    Greece

    Site Not Available

  • Novartis Investigative Site

    Budapest, HUN 1204
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Gyor, H-9023
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Dublin 4, D04 T6F
    Ireland

    Site Not Available

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Novartis Investigative Site

    Catania, CT 95123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50134
    Italy

    Site Not Available

  • Novartis Investigative Site

    Genova, GE 16132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 189
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Mexico, Distrito Federal 05300
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Amsterdam,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Bergen, 5021
    Norway

    Site Not Available

  • Novartis Investigative Site

    Lubin, 20-089
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warszawa, 02-957
    Poland

    Site Not Available

  • Novartis Investigative Site

    Amadora, 2720-276
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Bucharest, 050098
    Romania

    Site Not Available

  • Novartis Investigative Site

    Moscow, 127018
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Jeddah, 21499
    Saudi Arabia

    Site Not Available

  • Novartis Investigative Site

    Riyadh, 11211
    Saudi Arabia

    Site Not Available

  • Novartis Investigative Site

    Bratislava, Slovak Republic 811 07
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Maribor, 2000
    Slovenia

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41071
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28222
    Spain

    Site Not Available

  • Novartis Investigative Site

    Goeteborg, 413 45
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Bern, 3010
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    St Gallen, 9007
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • Novartis Investigative Site

    Dubai,
    United Arab Emirates

    Site Not Available

  • Novartis Investigative Site

    Brighton, RH16 4EX
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Norwich, NR1 3SR
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Novarris Investigative Site

    Stoke-on-Trent, ST4 7LN
    United Kingdom

    Site Not Available

  • Private Practice

    Fontana, California 92335
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Collins, Colorado 907-280528
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Palm Beach Obestectrics and Gynecology

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Novartis Investigative Site

    Cambridge, Massachusetts 02139
    United States

    Site Not Available

  • Newton-Wellesley Hospital

    Newton, Massachusetts 02462
    United States

    Site Not Available

  • Saint Mary's Health Care

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Research Neurology Associates

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Cleveland Clinic - Las Vegas

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • UMDNJ New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Novartis Investigative Site

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Novartis Investigative Site

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Westmoreland Neurology

    Greensburg, Pennsylvania 15601
    United States

    Site Not Available

  • Hospital of Univ of Penn

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Services Group Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Novartis Investigative Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Centro Medical San Antonio

    San Antonio, Texas 78221
    United States

    Site Not Available

  • Multiple Sclerosis Center of Tidewater

    Norfolk, Virginia 23502-3932
    United States

    Site Not Available

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