A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod (FLUENT)

A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]

A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

Study Overview

• Status: Completed
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod

Detailed Description

This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The first cohort was to be comprised of approximately 200 patients with RMS, who were newly prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to be comprised of approximately 200 RMS patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Novartis Investigative Site
    • Cullman, Alabama, United States, 35058
      • Novartis Investigative Site
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Novartis Investigative Site
  • California
    • Berkeley, California, United States, 94705
      • Novartis Investigative Site
    • Sacramento, California, United States, 95817
      • Novartis Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Novartis Investigative Site
    • Louisville, Colorado, United States, 80027
      • Novartis Investigative Site
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Novartis Investigative Site
    • Boca Raton, Florida, United States, 33482
      • Novartis Investigative Site
    • Jacksonville, Florida, United States, 32209
      • Novartis Investigative Site
    • Miami, Florida, United States, 33136
      • Novartis Investigative Site
    • Ocala, Florida, United States, 34471
      • Novartis Investigative Site
    • Port Charlotte, Florida, United States, 33952
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34243
      • Novartis Investigative Site
    • Sunrise, Florida, United States, 33351
      • Novartis Investigative Site
    • Vero Beach, Florida, United States, 32960
      • Novartis Investigative Site
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Novartis Investigative Site
    • Suwanee, Georgia, United States, 30024
      • Novartis Investigative Site
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Novartis Investigative Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Novartis Investigative Site
    • Louisville, Kentucky, United States, 40207
      • Novartis Investigative Site
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • Novartis Investigative Site
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Novartis Investigative Site
    • Lexington, Massachusetts, United States, 02421
      • Novartis Investigative Site
    • Wellesley, Massachusetts, United States, 02481
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Novartis Investigative Site
    • Owosso, Michigan, United States, 48867
      • Novartis Investigative Site
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Novartis Investigative Site
    • Saint Louis, Missouri, United States, 63131
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Novartis Investigative Site
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • Novartis Investigative Site
    • Livingston, New Jersey, United States, 07039
      • Novartis Investigative Site
  • New York
    • Patchogue, New York, United States, 11772
      • Novartis Investigative Site
    • Plainview, New York, United States, 11803
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28207
      • Novartis Investigative Site
    • Mooresville, North Carolina, United States, 28117
      • Novartis Investigative Site
    • Raleigh, North Carolina, United States, 27607
      • Novartis Investigative Site
    • Winston-Salem, North Carolina, United States, 27103
      • Novartis Investigative Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Novartis Investigative Site
    • Dayton, Ohio, United States, 45408
      • Novartis Investigative Site
    • Toledo, Ohio, United States, 43623
      • Novartis Investigative Site
    • Westerville, Ohio, United States, 43081
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Novartis Investigative Site
    • Oklahoma City, Oklahoma, United States, 73102
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97225
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Novartis Investigative Site
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Novartis Investigative Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Novartis Investigative Site
    • Port Royal, South Carolina, United States, 29935
      • Novartis Investigative Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37215
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78258
      • Novartis Investigative Site
  • Virginia
    • Falls Church, Virginia, United States, 22043
      • Novartis Investigative Site
    • Vienna, Virginia, United States, 22182
      • Novartis Investigative Site
  • Washington
    • Kirkland, Washington, United States, 98034
      • Novartis Investigative Site
    • Seattle, Washington, United States, 98122
      • Novartis Investigative Site
    • Spokane, Washington, United States, 99202
      • Novartis Investigative Site
    • Tacoma, Washington, United States, 98405
      • Novartis Investigative Site
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Novartis Investigative Site
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Novartis Investigative Site
    • Milwaukee, Wisconsin, United States, 53215
      • Novartis Investigative Site
    • Neenah, Wisconsin, United States, 54956
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of relapsing forms of Multiple Sclerosis
• Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

• Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
• History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
• Baseline QTc interval ≥ 500 msec
• Treatment with Class Ia or Class III anti-arrhythmic drugs
• Patients who had a hypersensitivity reaction to fingolimod or any of the excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day	Drug: Fingolimod; Commercially available 0.5mg hard capsules, taken orally once per day
Other: Cohort 2; RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years	Drug: Fingolimod; Commercially available 0.5mg hard capsules, taken orally once per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Monocytes (CD14+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Neutrophils (CD16+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in NK Cells (CD56+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Monocytes (CD14+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Neutrophils (CD16+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in NK Cells (CD56+)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)	Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.	Baseline to Month 12
Multiple Sclerosis (MS) Relapses During Treatment	A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.	Baseline to Month 12
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment	A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.	Baseline to Month 12
Change From Baseline in Patient Determined Disease Steps (PDDS)	PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.	Baseline to Month 12
Change From Baseline in T2 Lesion Burden		Baseline to Month 12
Change From Baseline for New Gd-Enhancing T1 Lesion Count		Baseline to Month 12
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)		Baseline to Month 6 and 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Relapsing Multiple Sclerosis; adult; MS; Fingolimod; FTY720; RMS; Multiple Sclerosis (MS); Relapsing Multiple Sclerosis (RMS); FLUENT; Immune Phenotype
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720DUS40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No