Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720107
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Relapsing-remitting Multiple Sclerosis
Intervention Drug: fingolimod
Enrollment 133
Recruitment Details  
Pre-assignment Details There were 133 patients enrolled in the study but only 130 received drug
Arm/Group Title Fingolimod
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 130
Completed 130
Not Completed 0
Arm/Group Title Fingolimod
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants
40.1  (8.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants
Female
83
  63.8%
Male
47
  36.2%
Multiple Sclerosis History at screening of CFTY720DDE01 (Core)   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants
Difference of first symptons and diagnosis 2.4  (3.56)
Difference of dagnosis and tx start in Core 8.6  (6.23)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
required baseline and month 48 visit measurement of the respective cell count
Arm/Group Title Fingolimod
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 130
Least Squares Mean (Standard Error)
Unit of Measure: percentage of parent population
CD4+ Naïve T cells Number Analyzed 121 participants
-23.7  (0.62)
CD4+Central memory T cells Number Analyzed 120 participants
-1.2  (0.59)
CD4+ Effector memory T cells Number Analyzed 121 participants
22.2  (2.37)
CD8+ Naïve T cells Number Analyzed 121 participants
-37.2  (0.38)
CD8+ Central memory T cells Number Analyzed 121 participants
-1.6  (0.07)
CD8+ Effector memory T cells Number Analyzed 121 participants
-12.9  (1.59)
TH17 central memory cells Number Analyzed 35 participants
-0.6  (0.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD4+ Naïve T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD4+ Central memory T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0493
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD4+ Effector memory T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD8+ Naïve T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD8+ Central memory T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments CD8+ Effector memory T cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Fingolimod
Comments TH17 central memory cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments 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
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fingolimod
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
21.54
3.Secondary Outcome
Title Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fingolimod
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
4.Secondary Outcome
Title Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
analysis required valid samples for baseline and month 48
Arm/Group Title Fingolimod
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 130
Least Squares Mean (Standard Error)
Unit of Measure: percentage of parent population
B cells Number Analyzed 95 participants
-7.2  (0.42)
Monocytes Number Analyzed 95 participants
42.3  (2.03)
Natural Killer cells Number Analyzed 82 participants
28.0  (2.09)
Time Frame (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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod 0.5 mg
Hide Arm/Group Description fingolimod 0.5 mg
All-Cause Mortality
Fingolimod 0.5 mg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Fingolimod 0.5 mg
Affected / at Risk (%)
Total   0/130 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fingolimod 0.5 mg
Affected / at Risk (%)
Total   1/130 (0.77%) 
Investigations   
Blood immunoglobulin M decreased  1  1/130 (0.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02720107    
Other Study ID Numbers: CFTY720DDE01E1
First Submitted: March 21, 2016
First Posted: March 25, 2016
Results First Submitted: November 14, 2017
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019