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The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fingolimod | Experimental | Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fingolimod | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Aim of trial was to was to show reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of 2 types of effector memory T cells TEM (CCR7- CD45RA-) and TEMRA (CCR7- CD45RA+) in peripheral venous blood. Changes from baseline to month 48 in biomarkers were analyzed for all patients in the FAS. | Baseline up to approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0. |
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Inclusion Criteria:
Exclusion criteriat:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ostfildern | Baden-Wurttemberg | 73760 | Germany | ||
| Novartis Investigative Site |
There were 133 patients enrolled in the study but only 130 received drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod | Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline up to approximately 48 months |
| Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0. | Baseline, month 6 up to approximately 48 months |
| Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) | Changes in immune status of B cells (CD19+, CD20+, CD69+), monocytes (CD14+) and NK cells (CD56+) were analyzed as a percentage of parent cell population (CD4+, CD8+ or total lymphocytes) by flow cytometry | Baseline up to approximately 48 months |
| Altenholz-Stift |
| Germany |
| 24161 |
| Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Berlin | 10713 | Germany |
| Novartis Investigative Site | Berlin | 12163 | Germany |
| Novartis Investigative Site | Berlin | 13347 | Germany |
| Novartis Investigative Site | Böblingen | 71032 | Germany |
| Novartis Investigative Site | Celle | 29223 | Germany |
| Novartis Investigative Site | Dortmund | 44137 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Erbach im Odenwald | 64711 | Germany |
| Novartis Investigative Site | Frankfurt | 60313 | Germany |
| Novartis Investigative Site | Göttingen | 37073 | Germany |
| Novartis Investigative Site | Jena | 07740 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Klingenmünster | 76889 | Germany |
| Novartis Investigative Site | Lappersdorf | 93138 | Germany |
| Novartis Investigative Site | Leverkusen | 51375 | Germany |
| Novartis Investigative Site | Mönchengladbach | 41239 | Germany |
| Novartis Investigative Site | München | 81829 | Germany |
| Novartis Investigative Site | Neuburg an der Donau | 86633 | Germany |
| Novartis Investigative Site | Siegen | 57076 | Germany |
| Novartis Investigative Site | Singen | 78224 | Germany |
| Novartis Investigative Site | Troisdorf | 53844 | Germany |
| Novartis Investigative Site | Ulm | 89073 | Germany |
| Novartis Investigative Site | Unterhaching | 82008 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod | Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||
| Multiple Sclerosis History at screening of CFTY720DDE01 (Core) | Difference in years between first symptoms of Multiple Sclerosis (MS)and diagnosis is calculated as date of diagnosis minus date of first symptoms Difference between diagnosis and treatment start in Core is calculated as date of first treatment in Core minus date of diagnosis. | Mean | Standard Deviation | years |
|
| 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 | Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Aim of trial was to was to show reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of 2 types of effector memory T cells TEM (CCR7- CD45RA-) and TEMRA (CCR7- CD45RA+) in peripheral venous blood. Changes from baseline to month 48 in biomarkers were analyzed for all patients in the FAS. | required baseline and month 48 visit measurement of the respective cell count | Posted | Least Squares Mean | Standard Error | percentage of parent population | Baseline up to approximately 48 months |
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| Secondary | Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0. | Posted | Number | percentage of participants | Baseline up to approximately 48 months |
|
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| Secondary | Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, month 6 up to approximately 48 months |
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| Secondary | Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) | Changes in immune status of B cells (CD19+, CD20+, CD69+), monocytes (CD14+) and NK cells (CD56+) were analyzed as a percentage of parent cell population (CD4+, CD8+ or total lymphocytes) by flow cytometry | analysis required valid samples for baseline and month 48 | Posted | Least Squares Mean | Standard Error | percentage of parent population | Baseline up to approximately 48 months |
|
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(Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.(approximately 48 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fingolimod 0.5 mg | fingolimod 0.5 mg | 0 | 130 | 1 | 130 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood immunoglobulin M decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
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 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| 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 |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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| CD4+ Effector memory T cells |
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| CD8+ Naïve T cells |
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| CD8+ Central memory T cells |
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| CD8+ Effector memory T cells |
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| TH17 central memory cells |
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| ANCOVA |
| 0.0493 |
The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study |
| Superiority or Other |
| CD4+ Effector memory T cells | ANCOVA | < 0.0001 | The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study | Superiority or Other |
| CD8+ Naïve T cells | ANCOVA | < 0.0001 | The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study | Superiority or Other |
| CD8+ Central memory T cells | ANCOVA | < 0.0001 | The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study | Superiority or Other |
| CD8+ Effector memory T cells | ANCOVA | < 0.0001 | The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study | Superiority or Other |
| TH17 central memory cells | ANCOVA | < 0.0001 | The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study | Superiority or Other |
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