Clinical trial NCT00662649: Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Official title: An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis.
Relapse-remitting
Fingolimod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 920
Sex: ALL
Minimum age (years): 20
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).


Eligibility criteria: Inclusion Criteria:

* Patients should complete the 24 month core study

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
timeFrame: Months 0 to end of study (maximum up to 60 months)
measure: Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
timeFrame: Core baseline to end of study (maximum up to 60 months)
measure: Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
timeFrame: Months 0-24 (core study) and Months 24-48 (extension study)
measure: Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
timeFrame: Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcomes:
measure: Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
timeFrame: Months 0-24 (core study) and Months 24-48 (extension study)
measure: Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
timeFrame: Months 0-24 (core study) and Months 24-48 (extension study)
measure: Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
timeFrame: Months 0-24 (core study) and Months 24-48 (extension study)
measure: Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
timeFrame: Months 0 to end of study (maximum up to 60 months)
measure: Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
timeFrame: Core baseline to end of study (maximum up to 60 months)
Other outcomes:
Locations:
city: Chatswood
country: Australia
facility: Novartis Investigative Site
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
city: Heidelberg
country: Australia
facility: Austin Health, Department of Neurology
city: North Gosford
country: Australia
facility: Novartis Investigative Site
city: Woodville
country: Australia
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Overpelt
country: Belgium
facility: Novartis Investigative Site
city: Sijsele - Damme
country: Belgium
facility: Novartis Investigative Site
city: Sint-Truiden
country: Belgium
facility: Novartis Investigative Site
city: Halifax
country: Canada
facility: Novartis Investigative Site
city: Kingston
country: Canada
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Nepean
country: Canada
facility: Novartis Investigative Site
city: Regina
country: Canada
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
city: Brno
country: Czech Republic
facility: Novartis Investigative Site
city: Olomouc
country: Czech Republic
facility: Novartis Investigative Site
city: Ostrava-Poruba
country: Czech Republic
facility: Novartis Investigative Site
city: Pardubice
country: Czech Republic
facility: Novartis Investigative Site
city: Plzen - Lochotin
country: Czech Republic
facility: Novartis Investigative Site
city: Prague 5
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 2
country: Czech Republic
facility: Novartis Investigative Site
city: Rychnov nad Kneznou
country: Czech Republic
facility: Novartis Investigative Site
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
city: Talinn
country: Estonia
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Clermont Ferrand Cedex
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Paris Cedex 13
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Gießen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novaratis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Safed
country: Israel
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Nieuwegein
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Sittard
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Lasi
country: Romania
facility: Novartis Investigative Site
city: Tg. Mures
country: Romania
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigational Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigational Site
city: Cape Town
country: South Africa
facility: Novartis Investigational Site
city: Rosebank
country: South Africa
facility: Novartis Investigational Site
city: Umhlanga
country: South Africa
facility: Novartis Investigational Site
city: Göteborg
country: Sweden
facility: Novartis Investigational Site
city: Stockholm
country: Sweden
facility: Novartis Investigational Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigational Site
city: Bursa
country: Turkey
facility: Novartis Investigational Site
city: Cerrahpasa/Istanbul
country: Turkey
facility: Novartis Investigational Site
city: Gaziantep
country: Turkey
facility: Novartis Investigational Site
city: Istanbul
country: Turkey
facility: Novartis Investigational Site
city: Izmir
country: Turkey
facility: Novartis Investigational Site
city: Mersin
country: Turkey
facility: Novartis Investigational Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigational Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: