Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00662649
Registration number
NCT00662649
Ethics application status
Date submitted
17/04/2008
Date registered
21/04/2008
Date last updated
12/07/2012
Titles & IDs
Public title
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2007-004122-24
Query!
Secondary ID [2]
0
0
CFTY720D2301E1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod 0.5 mg
Treatment: Drugs - Fingolimod 1.25 mg
Experimental: Fingolimod 1.25 mg - Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.
Experimental: Fingolimod 0.5 mg - Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.
Experimental: Placebo-fingolimod - Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.
Experimental: Placebo-fingolimod 1.25 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.
Experimental: Placebo-fingolimod 0.5 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.
Treatment: Drugs: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Treatment: Drugs: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
Query!
Assessment method [1]
0
0
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Query!
Timepoint [1]
0
0
Months 0 to end of study (maximum up to 60 months)
Query!
Primary outcome [2]
0
0
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
Query!
Assessment method [2]
0
0
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (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). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
Query!
Timepoint [2]
0
0
Core baseline to end of study (maximum up to 60 months)
Query!
Primary outcome [3]
0
0
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Query!
Assessment method [3]
0
0
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Query!
Timepoint [3]
0
0
Months 0-24 (core study) and Months 24-48 (extension study)
Query!
Primary outcome [4]
0
0
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
Query!
Assessment method [4]
0
0
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Query!
Timepoint [4]
0
0
Months 0-24 (core study) and Months 24-48 (extension study)
Query!
Secondary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Query!
Timepoint [1]
0
0
Months 0-24 (core study) and Months 24-48 (extension study)
Query!
Secondary outcome [2]
0
0
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)
Query!
Assessment method [2]
0
0
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Query!
Timepoint [2]
0
0
Months 0-24 (core study) and Months 24-48 (extension study)
Query!
Secondary outcome [3]
0
0
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Query!
Assessment method [3]
0
0
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Query!
Timepoint [3]
0
0
Months 0-24 (core study) and Months 24-48 (extension study)
Query!
Secondary outcome [4]
0
0
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
Query!
Assessment method [4]
0
0
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Query!
Timepoint [4]
0
0
Months 0 to end of study (maximum up to 60 months)
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.
Query!
Timepoint [5]
0
0
Core baseline to end of study (maximum up to 60 months)
Query!
Eligibility
Key inclusion criteria
- Patients should complete the 24 month core study
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
58
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
920
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Chatswood
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Fitzroy
Query!
Recruitment hospital [3]
0
0
Austin Health, Department of Neurology - Heidelberg
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - North Gosford
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Woodville
Query!
Recruitment postcode(s) [1]
0
0
- Chatswood
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
- North Gosford
Query!
Recruitment postcode(s) [5]
0
0
- Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Brugge
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Bruxelles
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Charleroi
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Leuven
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Overpelt
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Sijsele - Damme
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Sint-Truiden
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Halifax
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Kingston
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
London
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Montreal
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Nepean
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Regina
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Toronto
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Vancouver
Query!
Country [16]
0
0
Czech Republic
Query!
State/province [16]
0
0
Brno
Query!
Country [17]
0
0
Czech Republic
Query!
State/province [17]
0
0
Olomouc
Query!
Country [18]
0
0
Czech Republic
Query!
State/province [18]
0
0
Ostrava-Poruba
Query!
Country [19]
0
0
Czech Republic
Query!
State/province [19]
0
0
Pardubice
Query!
Country [20]
0
0
Czech Republic
Query!
State/province [20]
0
0
Plzen - Lochotin
Query!
Country [21]
0
0
Czech Republic
Query!
State/province [21]
0
0
Prague 5
Query!
Country [22]
0
0
Czech Republic
Query!
State/province [22]
0
0
Praha 2
Query!
Country [23]
0
0
Czech Republic
Query!
State/province [23]
0
0
Rychnov nad Kneznou
Query!
Country [24]
0
0
Czech Republic
Query!
State/province [24]
0
0
Teplice
Query!
Country [25]
0
0
Estonia
Query!
State/province [25]
0
0
Talinn
Query!
Country [26]
0
0
Finland
Query!
State/province [26]
0
0
Helsinki
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Tampere
Query!
Country [28]
0
0
Finland
Query!
State/province [28]
0
0
Turku
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Clermont Ferrand Cedex
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Dijon
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Lille Cedex
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Marseille cedex 05
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Montpellier cedex 5
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Nantes
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Paris Cedex 13
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Rennes
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Strasbourg
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Berlin
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Duesseldorf
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Gießen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Hamburg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Leipzig
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Magdeburg
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Muenchen
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Muenster
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Regensburg
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Stuttgart
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Tübingen
Query!
Country [49]
0
0
Greece
Query!
State/province [49]
0
0
Athens
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Miskolc
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Szekesfehervar
Query!
Country [53]
0
0
Ireland
Query!
State/province [53]
0
0
Dublin 4
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Ashkelon
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Haifa
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Ramat Gan
Query!
Country [57]
0
0
Israel
Query!
State/province [57]
0
0
Safed
Query!
Country [58]
0
0
Netherlands
Query!
State/province [58]
0
0
Amsterdam
Query!
Country [59]
0
0
Netherlands
Query!
State/province [59]
0
0
Nieuwegein
Query!
Country [60]
0
0
Netherlands
Query!
State/province [60]
0
0
Nijmegen
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Rotterdam
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Sittard
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Tilburg
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Bialystok
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Gdansk
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Katowice
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Lodz
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Poznan
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Warsaw
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Warszawa
Query!
Country [71]
0
0
Romania
Query!
State/province [71]
0
0
Bucharest
Query!
Country [72]
0
0
Romania
Query!
State/province [72]
0
0
Craiova
Query!
Country [73]
0
0
Romania
Query!
State/province [73]
0
0
Lasi
Query!
Country [74]
0
0
Romania
Query!
State/province [74]
0
0
Tg. Mures
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Kazan
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Moscow
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
St. Petersburg
Query!
Country [78]
0
0
Slovakia
Query!
State/province [78]
0
0
Bratislava
Query!
Country [79]
0
0
Slovakia
Query!
State/province [79]
0
0
Martin
Query!
Country [80]
0
0
Slovakia
Query!
State/province [80]
0
0
Zilina
Query!
Country [81]
0
0
South Africa
Query!
State/province [81]
0
0
Cape Town
Query!
Country [82]
0
0
South Africa
Query!
State/province [82]
0
0
Rosebank
Query!
Country [83]
0
0
South Africa
Query!
State/province [83]
0
0
Umhlanga
Query!
Country [84]
0
0
Sweden
Query!
State/province [84]
0
0
Göteborg
Query!
Country [85]
0
0
Sweden
Query!
State/province [85]
0
0
Stockholm
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Lausanne
Query!
Country [87]
0
0
Switzerland
Query!
State/province [87]
0
0
Zuerich
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Ankara
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Bursa
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Cerrahpasa/Istanbul
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Gaziantep
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Istanbul
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Izmir
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Mersin
Query!
Country [95]
0
0
Turkey
Query!
State/province [95]
0
0
Yenisehir/Izmir
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Bristol
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
London
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Newcastle Upon Tyne
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Nottingham
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00662649
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00662649
Download to PDF