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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00340834
Registration number
NCT00340834
Ethics application status
Date submitted
19/06/2006
Date registered
21/06/2006
Date last updated
21/09/2017
Titles & IDs
Public title
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
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Scientific title
A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
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Secondary ID [1]
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CFTY720D2302E1
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Secondary ID [2]
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CFTY720D2302
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Universal Trial Number (UTN)
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Trial acronym
TRANSFORMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod 1.25 mg
Treatment: Drugs - Fingolimod 0.5 mg
Treatment: Drugs - Interferon ß-1a 30 µg
Experimental: Fingolimod 1.25 mg -
Experimental: Fingolimod 0.5 mg -
Active Comparator: Interferon ß-1a 30 µg -
Treatment: Drugs: Fingolimod 1.25 mg
Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon ß-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Treatment: Drugs: Fingolimod 0.5 mg
Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon ß-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Treatment: Drugs: Interferon ß-1a 30 µg
Core: Patients self-administered interferon ß-1a 30 µg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
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Assessment method [1]
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The 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
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Timepoint [1]
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Baseline to Month 12
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Secondary outcome [1]
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Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
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Assessment method [1]
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The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (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.
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Timepoint [1]
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Baseline to Month 12
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Secondary outcome [2]
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Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study
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Assessment method [2]
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The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
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Timepoint [2]
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Baseline to Month 12
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Secondary outcome [3]
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Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
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Assessment method [3]
0
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The 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
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Timepoint [3]
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Month 0 to end of study (up to approximately 4.5 years)
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Secondary outcome [4]
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Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
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Assessment method [4]
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The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (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.
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Timepoint [4]
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Month 12 to end of study (up to approximately 3.5 years)
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Secondary outcome [5]
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Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study
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Assessment method [5]
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The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
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Timepoint [5]
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Baseline to end of study (up to approximately 4.5 years)
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Eligibility
Key inclusion criteria
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
(MS)
- Patients with a relapsing-remitting disease course
- Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5
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Minimum age
18
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with other chronic disease of the immune system, malignancies, acute
pulmonary disease, cardiac failure, etc
- Pregnant or nursing women
- Patients who cannot tolerate treatment with an interferon
Other protocol-defined inclusion/exclusion criteria applied to the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2011
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Sample size
Target
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Accrual to date
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Final
1292
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Strategic Health Evaluators - Chatswood
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Department of Medicine, Level, Missenden R, Camperdown
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Recruitment hospital [3]
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Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street - Liverpool
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Recruitment hospital [4]
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Gosford Private Hospital - North Gosford
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Recruitment hospital [5]
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St George Private Hospital - Suite 7E, Level 5, South Street, Kogarah
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Recruitment hospital [6]
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Box Hill Hopsital, Level 3, 16 Arnold Street - Box Hill
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Recruitment hospital [7]
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Royal Melbourne Hospital - Suite 30, Grattan St., Parkbville
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2067 - Chatswood
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Recruitment postcode(s) [2]
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2050 - Department of Medicine, Level, Missenden R, Camperdown
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2170 - Liverpool
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2250 - North Gosford
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2217 - Suite 7E, Level 5, South Street, Kogarah
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3050 - Suite 30, Grattan St., Parkbville
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Recruitment outside Australia
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Cordoba
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Argentina
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General Urquiza 609, Buenos Aires
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Argentina
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Montaneses 2325, Buenos Aires
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Austria
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Sankt Poelten
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Austria
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Abteilung fuer Neurologie, Linz
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Austria
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Anichstrasse 35, Innsbruck
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Ignaz Harrerstr. 79 , Salzburg
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Vienna
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Avenue Hippocrate 10, Bruxelles
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Laarbeeklaan 101, Brussels
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Korhaz u. 1, Veszprem
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Pecs
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u. 8-20m, Budapest
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Uzsoki u. 29., Budapest
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piazza Giulio Cesare, 11 Bari
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via Antonio De Toni, 5, Genova
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via dei Vestini, 5 Chieti
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via Montpellier, 1, Roma
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via Olgettina, 48/60, Milano
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via Pansini, 5, Napoli
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via Santa Sofia, 78, Catania
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via Toscana Nazionale, 17/19, Bologna
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Korea, Republic of
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Goyang
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Korea, Republic of
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State/province [107]
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Seoul
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Country [108]
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Korea, Republic of
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State/province [108]
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Taegu
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Country [109]
0
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Portugal
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State/province [109]
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Amadora
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Country [110]
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Portugal
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State/province [110]
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Av. Dr. Bissaya Barreto, Coimbra
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Country [111]
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Portugal
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State/province [111]
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Capuchos
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Country [112]
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Portugal
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State/province [112]
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Porto
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Country [113]
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Portugal
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State/province [113]
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Rua Camilo Castelo Branco, Setubal
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Country [114]
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Spain
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State/province [114]
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Avda. Carlos Haya, s/n, Málaga
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Country [115]
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Spain
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State/province [115]
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Avenida Dr. Fedriani, 3, Sevilla
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Country [116]
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Spain
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State/province [116]
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Barcelona
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Country [117]
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Spain
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State/province [117]
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Bilbao
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Country [118]
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Spain
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State/province [118]
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C/ Dr. Martin Lagos, s/n, Madrid
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Country [119]
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Spain
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State/province [119]
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EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona
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Country [120]
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Spain
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State/province [120]
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San Martin de Porres, 4, Madrid
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Spain
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State/province [121]
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Valencia
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Country [122]
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Switzerland
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State/province [122]
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Neurologische Klinik, Frauenklinikstrasse 26, Zuerich
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Country [123]
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Switzerland
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State/province [123]
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Petersgraben 4, Basel
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Country [124]
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United Kingdom
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State/province [124]
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Investigational Site
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Country [125]
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United Kingdom
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State/province [125]
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London
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Country [126]
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United Kingdom
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State/province [126]
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Lower Lane, Fazakerly, Liverpool
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Country [127]
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United Kingdom
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State/province [127]
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Norwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod
versus interferon ß-1a to reduce the frequency of relapses in patients with
relapsing-remitting multiple sclerosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00340834
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmacuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00340834
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