Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis Clinical Trial

Official title:

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201356
• Other study ID #: CFTY720D2399
• Secondary ID: 2010-020515-37
• Status: Completed
• Phase: Phase 3
• Start date: September 13, 2010
• Est. completion date: October 19, 2018

Study information

• Verified date: March 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

Description:

This study had two parts:

• Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and

• Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4125
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Patients who have completed selected ongoing or planned trials with FTY720.

Key Exclusion Criteria:

• Premature permanent discontinuation of a previous fingolimod study.

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.

• Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.

• Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.

• Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.

• Previous treatment with cladribine, cyclophosphamide or mitoxantrone.

• Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:

• Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

• Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;

• Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;

• Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)

• History or presence of a third degree AV block

• Proven history of sick sinus syndrome or sino-atrial heart block

• Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

• Any of the following pulmonary conditions during the previous fingolimod study:

• Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)

• Active tuberculosis

• Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod
0.5 mg/day

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Capital Federal	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Salta	Provincia De Salta
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Guaymallen	Mendoza
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Miguel de Tucumán	Tucumán
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Chatswood	New South Wales
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	North Gosford	New South Wales
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Woodville	South Australia
Austria	Novartis Investigative Site	Innsbruck	Tyrol
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	St Poelten
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Fraiture En Condroz
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Melsbroek
Belgium	Novartis Investigative Site	Pelt
Belgium	Novartis Investigative Site	Sijsele
Belgium	Novartis Investigative Site	Sint-Truiden
Belgium	Novartis Investigative Site	Wilrijk
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Rio De Janiero	RJ
Canada	Novartis Investigative Site	Burnaby	British Columbia
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Kingston	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Nepean	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Regina	Saskatchewan
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Olomouc	CZE
Czechia	Novartis Investigative Site	Ostrava-Poruba
Czechia	Novartis Investigative Site	Pardubice
Czechia	Novartis Investigative Site	Plzen - Lochotin
Czechia	Novartis Investigative Site	Prague 5
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Rychnov nad Kneznou
Czechia	Novartis Investigative Site	Teplice
Denmark	Novartis Investigative Site	Aarhus
Denmark	Novartis Investigative Site	Copenhagen
Egypt	Novartis Investigative Site	Alexandria
Egypt	Novartis Investigative Site	Cairo
Egypt	Novartis Investigative Site	Cairo
Estonia	Novartis Investigative Site	Tallinn
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Seinajoki
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Bron
France	Novartis Investigative Site	CAEN Cedex
France	Novartis Investigative Site	Clermont-Ferrand Cedex 1
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nancy	Cedex
France	Novartis Investigative Site	Nice Cedex 1
France	Novartis Investigative Site	Paris Cedex 13
France	Novartis Investigative Site	Poissy
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	St Herblain
France	Novartis Investigative Site	Strasbourg Cedex
France	Novartis Investigative Site	Toulouse cedex 9
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Aalen
Germany	Novartis Investigative Site	Abensberg
Germany	Novartis Investigative Site	Achim
Germany	Novartis Investigative Site	Alzenau
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Honnef
Germany	Novartis Investigative Site	Bad Krozingen
Germany	Novartis Investigative Site	Bad Mergentheim
Germany	Novartis Investigative Site	Bad Neustadt
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Boblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bogen
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Buchholz
Germany	Novartis Investigative Site	Buchholz in der Nordheide
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dillingen
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Emden
Germany	Novartis Investigative Site	Emmendingen
Germany	Novartis Investigative Site	Erbach
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Grevenbroich
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Hennigsdorf
Germany	Novartis Investigative Site	Herborn
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Ibbenbueren
Germany	Novartis Investigative Site	Itzehoe
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kaltenkirchen
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Krefeld
Germany	Novartis Investigative Site	Landshut
Germany	Novartis Investigative Site	Lappersdorf
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lohr am Main
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Munich	Bavaria
Germany	Novartis Investigative Site	Nagold
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Neuburg an der Donau
Germany	Novartis Investigative Site	Neuruppin
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Ostfildern	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Prien
Germany	Novartis Investigative Site	Regensburg	Bavaria
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigative Site	Ruelzheim
Germany	Novartis Investigative Site	Schwarzenbruck
Germany	Novartis Investigative Site	Schwendi
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sinsheim
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Teupitz
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Tübingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Unterhaching
Germany	Novartis Investigative Site	Wendlingen
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wuerzburg
Germany	Novartis Investigative Site	Wuppertal
Germany	Novartis Investigative Site	Würzburg
Greece	Novartis Investigative Site	Alexandroupolis	Evros
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion Crete
Greece	Novartis Investigative Site	Patras
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki	GR
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest	HUN
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar
Hungary	Novartis Investigative Site	Veszprem
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin 4
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Sefad
Italy	Novartis Investigative Site	Acquaviva delle Fonti	BA
Italy	Novartis Investigative Site	Asti	AT
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Fidenza	PR
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Foggia	FG
Italy	Novartis Investigative Site	Gallarate	VA
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Montichiari	BS
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Ravenna	RA
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Udine	UD
Italy	Novartis Investigative Site	Verona	VR
Italy	Novartis Investigative Site	Vicenza	VI
Italy	Novartis Investigative Site	Viterbo	VT
Jordan	Novartis Investigative Site	Irbid
Korea, Republic of	Novartis Investigative Site	Gyeonggi do	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Blaricum
Netherlands	Novartis Investigative Site	Breda	CK
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Gouda
Netherlands	Novartis Investigative Site	Nieuwegein
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Sittard-Geleen
Netherlands	Novartis Investigative Site	Tilburg
Norway	Novartis Investigative Site	Lillehammer
Norway	Novartis Investigative Site	Molde
Norway	Novartis Investigative Site	Stavanger
Panama	Novartis Investigative Site	Panama City
Panama	Novartis Investigative Site	Panama City
Peru	Novartis Investigative Site	Jesus Maria	Lima
Peru	Novartis Investigative Site	La Perla	Callao
Peru	Novartis Investigative Site	San Isidro	Lima
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Portugal	Novartis Investigative Site	Amadora
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Setubal
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Targu Mures
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Samara	Samara Region
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	St. Petersburg
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Trnava
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Rosebank
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	L Hospitalet De Llobregat	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	San Sebastian	Pais Vasco
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Sweden	Novartis Investigative Site	Goeteborg
Sweden	Novartis Investigative Site	Linkoping
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Umea
Switzerland	Novartis Investigative Site	Aarau
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Carouge
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Lugano
Switzerland	Novartis Investigative Site	St Gallen
Switzerland	Novartis Investigative Site	Zuerich
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Gaziantep
Turkey	Novartis Investigative Site	Haseki / Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Samsun
Turkey	Novartis Investigative Site	Trabzon
Turkey	Novartis Investigative Site	Yenisehir / Izmir
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Brighton	East Sussex
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Dundee
United Kingdom	Novartis Investigative Site	Edinburgh
United Kingdom	Novartis Investigative Site	Essex
United Kingdom	Novartis Investigative Site	Great Yarmouth
United Kingdom	Novartis Investigative Site	Headington	Oxfordshire
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Middlesbrough
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Northampton
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Poole
United Kingdom	Novartis Investigative Site	Salford	Manchester
United Kingdom	Novartis Investigative Site	Sheffield	South Yorkshire
United Kingdom	Novartis Investigative Site	Stoke on Trent	Staffordshire
United Kingdom	Novartis Investigative Site	Swindon
United Kingdom	Novartis Investigative Site	Truro	Cornwall
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Bristol	Tennessee
United States	Novartis Investigative Site	Burlington	Vermont
United States	Novartis Investigative Site	Charlottesville	Virginia
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United States	Novartis Investigative Site	Maitland	Florida
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United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Sunrise	Florida
United States	Novartis Investigative Site	Tallahassee	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Tualatin	Oregon
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Vero Beach	Florida
United States	Novartis Investigative Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  Egypt,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  Ireland,  Israel,  Italy,  Jordan,  Korea, Republic of,  Malaysia,  Netherlands,  Norway,  Panama,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death	Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.	Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
Secondary	Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod	Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Secondary	Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod	A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.; In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Secondary	Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod	Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Study (an average of Month 156)
Secondary	Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume	Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.	Month 3 to End of Study (Study Completion Visit)
Secondary	Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume	T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.	Month 3 to End of Study (Study Completion Visit)
Secondary	Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod	Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.	Month 3 to Month 156
Secondary	Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod	The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = [(SIENA/100+1) ^ (365.25/#days)-1]*100 where SIENA=(Vk/V0-1)*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.	Month 3 to Month 156
Secondary	Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod	Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of >=1 and <=5.5, and by 0.5 points for patients with an FDF baseline EDSS>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.	Month 12 to Month 156
Secondary	Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration.; If baseline EDSS score is <=5, improvement is indicated by an EDSS score change of <= -1, stable is indicated by an EDSS score change of > -1 and <= 0.5, deterioration is indicated by an EDSS score change of > 0.5; if baseline EDSS score is > 5, improvement is indicated by an EDSS score change of <= -0.5, stable is indicated by an EDSS score change of > -0.5 and <= 0, deterioration is indicated by an EDSS score change of > 0. Only descriptive analysis performed.	Month 3 to Month 6 Follow-up
Secondary	Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)