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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004122-24 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod 1.25 mg | Experimental | 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. |
|
| Fingolimod 0.5 mg | Experimental | Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. |
|
| Placebo-fingolimod | Experimental | 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. |
|
| Placebo-fingolimod 1.25 mg | Experimental | Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. |
|
| Placebo-fingolimod 0.5 mg | Experimental | Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod 0.5 mg | Drug | Patients self-administered fingolimod 0.5 mg capsules orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study) | 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. | Months 0 to end of study (maximum up to 60 months) |
| Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free | 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. | Core baseline to end of study (maximum up to 60 months) |
| Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study) | 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. | Months 0-24 (core study) and Months 24-48 (extension study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chatswood | Australia | ||||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Fingolimod clinical trials information website | View source |
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Of the 1272 patients randomly assigned to treatment in the Core study (ClinicalTrials.gov ID NCT00289978), 1033 completed the 24-month double-blind treatment phase and were eligible to enter the Extension study. A total of 920 of the 1033 patients entered the Extension study and received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod 1.25 mg | Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study. |
| FG001 | Fingolimod 0.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study (24 Months) |
|
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|
| Fingolimod 1.25 mg | Drug | Patients self-administered fingolimod 1.25 mg capsules orally once daily. |
|
|
| Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study) | 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. | Months 0-24 (core study) and Months 24-48 (extension study) |
| Months 0-24 (core study) and Months 24-48 (extension study) |
| 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) | 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. | Months 0-24 (core study) and Months 24-48 (extension study) |
| Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study) | 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. | Months 0-24 (core study) and Months 24-48 (extension study) |
| Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study) | 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. | Months 0 to end of study (maximum up to 60 months) |
| 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 | 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. | Core baseline to end of study (maximum up to 60 months) |
| Fitzroy |
| 3065 |
| Australia |
| Austin Health, Department of Neurology | Heidelberg | Australia |
| Novartis Investigative Site | North Gosford | Australia |
| Novartis Investigative Site | Woodville | Australia |
| Novartis Investigative Site | Bruges | Belgium |
| Novartis Investigative Site | Brussels | Belgium |
| Novartis Investigative Site | Charleroi | Belgium |
| Novartis Investigative Site | Leuven | Belgium |
| Novartis Investigative Site | Overpelt | Belgium |
| Novartis Investigative Site | Sijsele - Damme | Belgium |
| Novartis Investigative Site | Sint-Truiden | Belgium |
| Novartis Investigative Site | Halifax | Canada |
| Novartis Investigative Site | Kingston | Canada |
| Novartis Investigative Site | London | Canada |
| Novartis Investigative Site | Montreal | Canada |
| Novartis Investigative Site | Nepean | Canada |
| Novartis Investigative Site | Regina | Canada |
| Novartis Investigative Site | Toronto | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Brno | Czechia |
| Novartis Investigative Site | Olomouc | Czechia |
| Novartis Investigative Site | Ostrava-Poruba | Czechia |
| Novartis Investigative Site | Pardubice | Czechia |
| Novartis Investigative Site | Plzen - Lochotin | Czechia |
| Novartis Investigative Site | Prague | Czechia |
| Novartis Investigative Site | Rychnov nad Kněžnou | Czechia |
| Novartis Investigative Site | Teplice | Czechia |
| Novartis Investigative Site | Talinn | Estonia |
| Novartis Investigative Site | Helsinki | Finland |
| Novartis Investigative Site | Tampere | Finland |
| Novartis Investigative Site | Turku | Finland |
| Novartis Investigative Site | Clermont-Ferrand | France |
| Novartis Investigative Site | Dijon | France |
| Novartis Investigative Site | Lille | France |
| Novartis Investigative Site | Marseille | France |
| Novartis Investigative Site | Montpellier | France |
| Novartis Investigative Site | Nantes | France |
| Novartis Investigative Site | Paris | France |
| Novartis Investigative Site | Rennes | France |
| Novartis Investigative Site | Strasbourg | France |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Düsseldorf | Germany |
| Novartis Investigative Site | Giessen | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Leipzig | Germany |
| Novartis Investigative Site | Magdeburg | Germany |
| Novartis Investigative Site | München | Germany |
| Novartis Investigative Site | Münster | Germany |
| Novartis Investigative Site | Regensburg | Germany |
| Novartis Investigative Site | Stuttgart | Germany |
| Novartis Investigative Site | Tübingen | Germany |
| Novartis Investigative Site | Athens | Greece |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Miskolc | Hungary |
| Novartis Investigative Site | Székesfehérvár | Hungary |
| Novartis Investigative Site | Dublin | Ireland |
| Novaratis Investigative Site | Ashkelon | Israel |
| Novartis Investigative Site | Haifa | Israel |
| Novartis Investigative Site | Ramat Gan | Israel |
| Novartis Investigative Site | Safed | Israel |
| Novartis Investigative Site | Amsterdam | Netherlands |
| Novartis Investigative Site | Nieuwegein | Netherlands |
| Novartis Investigative Site | Nijmegen | Netherlands |
| Novartis Investigative Site | Rotterdam | Netherlands |
| Novartis Investigative Site | Sittard | Netherlands |
| Novartis Investigative Site | Tilburg | Netherlands |
| Novartis Investigative Site | Bialystok | Poland |
| Novartis Investigative Site | Gdansk | Poland |
| Novartis Investigative Site | Katowice | Poland |
| Novartis Investigative Site | Lodz | Poland |
| Novartis Investigative Site | Poznan | Poland |
| Novartis Investigative Site | Warsaw | Poland |
| Novartis Investigative Site | Bucharest | Romania |
| Novartis Investigative Site | Craiova | Romania |
| Novartis Investigative Site | Lasi | Romania |
| Novartis Investigative Site | Tg. Mures | Romania |
| Novartis Investigative Site | Kazan' | Russia |
| Novartis Investigative Site | Moscow | Russia |
| Novartis Investigative Site | Saint Petersburg | Russia |
| Novartis Investigational Site | Bratislava | Slovakia |
| Novartis Investigative Site | Martin | Slovakia |
| Novartis Investigational Site | Žilina | Slovakia |
| Novartis Investigational Site | Cape Town | South Africa |
| Novartis Investigational Site | Rosebank | South Africa |
| Novartis Investigational Site | Umhlanga | South Africa |
| Novartis Investigational Site | Gothenburg | Sweden |
| Novartis Investigational Site | Stockholm | Sweden |
| Novartis Investigative Site | Lausanne | Switzerland |
| Novartis Investigative Site | Zurich | Switzerland |
| Novartis Investigational Site | Ankara | Turkey (Türkiye) |
| Novartis Investigational Site | Bursa | Turkey (Türkiye) |
| Novartis Investigational Site | Cerrahpasa/Istanbul | Turkey (Türkiye) |
| Novartis Investigational Site | Gaziantep | Turkey (Türkiye) |
| Novartis Investigational Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigational Site | Izmir | Turkey (Türkiye) |
| Novartis Investigational Site | Mersin | Turkey (Türkiye) |
| Novartis Investigational Site | Yenisehir/Izmir | Turkey (Türkiye) |
| Novartis Investigative Site | Bristol | United Kingdom |
| Novartis Investigative Site | London | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | United Kingdom |
| Novartis Investigative Site | Nottingham | United Kingdom |
| Novartis Investigative Site | Sheffield | United Kingdom |
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
| FG002 | Placebo | Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study. |
| FG003 | 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. |
| FG004 | Placebo-fingolimod 0.5 | Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study. |
| Intent to Treat (ITT) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Study (Month 24 to 60) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod 1.25 mg | Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All demographic measurements are based on extension randomized/safety population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study) | 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. | Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. | Posted | Number | 95% Confidence Interval | Relapses per year | Months 0 to end of study (maximum up to 60 months) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans. | Posted | Mean | Standard Deviation | Lesions | Months 0-24 (core study) and Months 24-48 (extension study) |
| |||||||||||||||||||||||||||||||||
| Primary | Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free | 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. | Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. | Posted | Number | 95% Confidence Interval | Percentage of patients | Core baseline to end of study (maximum up to 60 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans. | Posted | Number | Percentage of patients | Months 0-24 (core study) and Months 24-48 (extension study) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study) | 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. | Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. | Posted | Mean | Standard Deviation | Percent change | Months 0-24 (core study) and Months 24-48 (extension study) |
| |||||||||||||||||||||||||||||||||
| Primary | Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study) | 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. | Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. | Posted | Number | 95% Confidence Interval | Relapses per year | Months 0-24 (core study) and Months 24-48 (extension study) |
| |||||||||||||||||||||||||||||||||
| Primary | Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study) | 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. | Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. | Posted | Number | 95% Confidence Interval | Ratio of relapses per year | Months 0-24 (core study) and Months 24-48 (extension study) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study) | 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. | Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study. | Posted | Mean | Standard Deviation | Percent change | Months 0 to end of study (maximum up to 60 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. | Posted | Number | 95% Confidence Interval | Percentage of patients | Core baseline to end of study (maximum up to 60 months) |
|
Not provided
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fingolimod 1.25mg | Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study. | 31 | 289 | 236 | 289 | ||
| EG001 | Fingolimod 0.5mg | Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study. | 31 | 331 | 273 | 331 | ||
| EG002 | Placebo-Fingolimod 1.25mg | Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study. | 17 | 145 | 107 | 145 | ||
| EG003 | Placebo-Fingolimod 0.5mg | Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study. | 11 | 155 | 130 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Genital infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Crush injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Borderline ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant neoplasm of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lymphomatoid papulosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Parapsoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Selective abortion | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Carbon monoxide diffusing capacity decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided
| Abnormal test procedure result(s) |
|
| Administrative problems |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Subject withdrew consent |
|
| Subject no longer requires study drug |
|
| Unsatisfactory therapeutic effect |
|
| Male |
|
Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study. |
| OG003 | 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. |
|
|
|
|
Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study. |
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study. |
| OG003 | 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. |
|
|
| 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. |
| OG003 | 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. |
|
|
|
|
| Placebo-fingolimod |
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study. |
|
|