The Gilenya Pregnancy Registry

NCT ID: NCT01285479

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-15

Study Completion Date

2024-05-29

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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fingolimod

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

Fingolimod

Intervention Type DRUG

fingolimod 0.5 mg/day, including generic versions of fingolimod

Interventions

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Fingolimod

fingolimod 0.5 mg/day, including generic versions of fingolimod

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Fort Lauderdale, Florida, United States

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Cambridge, Massachusetts, United States

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Grand Forks, North Dakota, United States

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Bahía Blanca, Buenos Aires, Argentina

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Córdoba, , Argentina

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Box Hill, Victoria, Australia

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Graz, , Austria

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Linz, , Austria

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Brasschaat, , Belgium

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Leuven, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Saint-Laurent, Quebec, Canada

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Bogotá, , Colombia

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Nicosia, , Cyprus

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Ostrava-Poruba, , Czechia

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Aalborg, , Denmark

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Sønderborg, , Denmark

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Tampere, , Finland

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Turku, , Finland

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Bron, , France

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Cahors, , France

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Bochum, , Germany

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Athens, GR, Greece

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Budapest, HUN, Hungary

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Győr, , Hungary

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Dublin, , Ireland

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Jerusalem, , Israel

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Ramat Gan, , Israel

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Catania, CT, Italy

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Florence, FI, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Roma, RM, Italy

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Orbassano, TO, Italy

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Beirut, , Lebanon

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Mexico City, Mexico City, Mexico

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Amsterdam, , Netherlands

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Lubin, , Poland

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Warsaw, , Poland

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Amadora, , Portugal

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Porto, , Portugal

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Bucharest, , Romania

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Moscow, , Russia

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Jeddah, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Bratislava, Slovak Republic, Slovakia

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Maribor, , Slovenia

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Seville, Andalusia, Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Basel, , Switzerland

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Bern, , Switzerland

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Lausanne, , Switzerland

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Sankt Gallen, , Switzerland

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Abu Dhabi, , United Arab Emirates

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Dubai, , United Arab Emirates

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Newcastle upon Tyne, , United Kingdom

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Norwich, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Canada Colombia Cyprus Czechia Denmark Finland France Germany Greece Hungary Ireland Israel Italy Lebanon Mexico Netherlands Poland Portugal Romania Russia Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland United Arab Emirates United Kingdom

Related Links

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https://www.gilenyapregnancyregistry.com

https://www.gilenyapregnancyregistry.com

Other Identifiers

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CFTY720D2404

Identifier Type: -

Identifier Source: org_study_id

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