A Phase 4 interventional study of fingolimod in Relapsing-remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Completed at 26 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Basic science
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 133 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteriat:
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).
Drug: fingolimod
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.
Time frame: Baseline up to approximately 48 months
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.
Time frame: 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.
Time frame: 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
Time frame: Baseline up to approximately 48 months
| Milestone | Fingolimod |
|---|---|
| Started | 130 |
| Completed | 130 |
| Not completed | 0 |
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.
| percentage of parent population | Fingolimod |
|---|---|
| CD4+ Naïve T cells | -23.7 ± 0.62 |
| CD4+Central memory T cells | -1.2 ± 0.59 |
| CD4+ Effector memory T cells | 22.2 ± 2.37 |
| CD8+ Naïve T cells | -37.2 ± 0.38 |
| CD8+ Central memory T cells | -1.6 ± 0.07 |
| CD8+ Effector memory T cells | -12.9 ± 1.59 |
| TH17 central memory cells | -0.6 ± 0.03 |
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.
| percentage of participants | Fingolimod |
|---|---|
| Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | 21.54 |
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.
| scores on a scale | Fingolimod |
|---|---|
| Baseline | 2.7 ± 1.17 |
| Month 6 | 2.6 ± 1.38 |
| Month 48 | 2.7 ± 1.52 |
| Change from baseline to month 6 | -0.1 ± 0.69 |
| Change from month 6 to month 48 | 0.2 ± 1.18 |
| Change from baseline to month 48 | 0.0 ± 1.19 |
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
| percentage of parent population | Fingolimod |
|---|---|
| B cells | -7.2 ± 0.42 |
| Monocytes | 42.3 ± 2.03 |
| Natural Killer cells | 28.0 ± 2.09 |
Collected over (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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod 0.5 mg | — | 0/130 (0%) | 1/130 (0.8%) |
| Event | Fingolimod 0.5 mg |
|---|---|
| Blood immunoglobulin M decreasedInvestigations | 1/130 |
| Age, Continuous(years) | Fingolimod |
|---|---|
| Mean | 40.1 ± 8.54 |
| Sex: Female, Male(Participants) | Fingolimod |
|---|---|
| Female | 83 |
| Male | 47 |
| Multiple Sclerosis History at screening of CFTY720DDE01 (Core)(years) | Fingolimod |
|---|---|
| Difference of first symptons and diagnosis | 2.4 ± 3.56 |
| Difference of dagnosis and tx start in Core | 8.6 ± 6.23 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals