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

• ClinicalTrials.gov Identifier: NCT03257358
• Recruitment Status: Completed
• First Posted: August 22, 2017
• Results First Posted: July 21, 2020
• Last Update Posted: October 7, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Relapsing Multiple Sclerosis	Drug: Fingolimod	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 382 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-cohort, non-randomized, open-label multicenter
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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]
• Actual Study Start Date: September 19, 2017
• Actual Primary Completion Date: March 5, 2019
• Actual Study Completion Date: June 28, 2019

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) [ Time Frame: Baseline to Month 6 ]
   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.
2. Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [ Time Frame: Baseline to Month 6 ]
   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.
3. Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [ Time Frame: Baseline to Month 6 ]
   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.
4. Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) [ Time Frame: Baseline to Month 6 ]
   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.
5. Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) [ Time Frame: Baseline to Month 6 ]
   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.
6. Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) [ Time Frame: Baseline to Month 6 ]
   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.
7. Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) [ Time Frame: Baseline to Month 6 ]
   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.
8. Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [ Time Frame: Baseline to Month 6 ]
   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.
9. Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [ Time Frame: Baseline to Month 6 ]
   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.
10. Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) [ Time Frame: Baseline to Month 6 ]
    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.
11. Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) [ Time Frame: Baseline to Month 6 ]
    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.
12. Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) [ Time Frame: Baseline to Month 6 ]
    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.
13. Change From Baseline to Month 6 in Monocytes (CD14+) [ Time Frame: Baseline to Month 6 ]
    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.
14. Change From Baseline to Month 6 in Neutrophils (CD16+) [ Time Frame: Baseline to Month 6 ]
    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.
15. Change From Baseline to Month 6 in NK Cells (CD56+) [ Time Frame: Baseline to Month 6 ]
    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.
16. Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count [ Time Frame: Baseline to Month 6 ]
    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.
17. Change From Baseline to Month 6 in Total CD4+ Differential Cell Count [ Time Frame: Baseline to Month 6 ]
    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.
18. Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count [ Time Frame: Baseline to Month 6 ]
    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.
19. Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) [ Time Frame: Baseline to Month 6 ]
    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.
20. Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count [ Time Frame: Baseline to Month 6 ]
    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.
21. Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) [ Time Frame: Baseline to Month 6 ]
    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.

Secondary Outcome Measures :

1. Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) [ Time Frame: Baseline to Month 12 ]
   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.
2. Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [ Time Frame: Baseline to Month 12 ]
   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.
3. Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [ Time Frame: Baseline to Month 12 ]
   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.
4. Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) [ Time Frame: Baseline to Month 12 ]
   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.
5. Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) [ Time Frame: Baseline to Month 12 ]
   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.
6. Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) [ Time Frame: Baseline to Month 12 ]
   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.
7. Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) [ Time Frame: Baseline to Month 12 ]
   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.
8. Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [ Time Frame: Baseline to Month 12 ]
   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.
9. Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [ Time Frame: Baseline to Month 12 ]
   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.
10. Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) [ Time Frame: Baseline to Month 12 ]
    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.
11. Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) [ Time Frame: Baseline to Month 12 ]
    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.
12. Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) [ Time Frame: Baseline to Month 12 ]
    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.
13. Change From Baseline to Month 12 in Monocytes (CD14+) [ Time Frame: Baseline to Month 12 ]
    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.
14. Change From Baseline to Month 12 in Neutrophils (CD16+) [ Time Frame: Baseline to Month 12 ]
    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.
15. Change From Baseline to Month 12 in NK Cells (CD56+) [ Time Frame: Baseline to Month 12 ]
    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.
16. Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count [ Time Frame: Baseline to Month 12 ]
    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.
17. Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) [ Time Frame: Baseline to Month 12 ]
    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.
18. Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count [ Time Frame: Baseline to Month 12 ]
    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.
19. Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) [ Time Frame: Baseline to Month 12 ]
    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.
20. Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count [ Time Frame: Baseline to Month 12 ]
    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.
21. Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) [ Time Frame: Baseline to Month 12 ]
    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.
22. Multiple Sclerosis (MS) Relapses During Treatment [ Time Frame: Baseline to Month 12 ]
    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.
23. Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment [ Time Frame: Baseline to Month 12 ]
    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.
24. Change From Baseline in Patient Determined Disease Steps (PDDS) [ Time Frame: Baseline to Month 12 ]
    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.
25. Change From Baseline in T2 Lesion Burden [ Time Frame: Baseline to Month 12 ]
26. Change From Baseline for New Gd-Enhancing T1 Lesion Count [ Time Frame: Baseline to Month 12 ]
27. Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) [ Time Frame: Baseline to Month 6 and 12 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Novartis Investigative Site

Birmingham, Alabama, United States, 35209

Novartis Investigative Site

Cullman, Alabama, United States, 35058

United States, Arizona

Novartis Investigative Site

Tucson, Arizona, United States, 85718

United States, California

Novartis Investigative Site

Berkeley, California, United States, 94705

Novartis Investigative Site

Sacramento, California, United States, 95817

United States, Colorado

Novartis Investigative Site

Colorado Springs, Colorado, United States, 80907

Novartis Investigative Site

Louisville, Colorado, United States, 80027

United States, Florida

Novartis Investigative Site

Boca Raton, Florida, United States, 33482

Novartis Investigative Site

Boca Raton, Florida, United States, 33487

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

United States, Georgia

Novartis Investigative Site

Savannah, Georgia, United States, 31406

Novartis Investigative Site

Suwanee, Georgia, United States, 30024

United States, Illinois

Novartis Investigative Site

Flossmoor, Illinois, United States, 60422

United States, Kansas

Novartis Investigative Site

Kansas City, Kansas, United States, 66160

United States, Kentucky

Novartis Investigative Site

Louisville, Kentucky, United States, 40202

Novartis Investigative Site

Louisville, Kentucky, United States, 40207

United States, Maryland

Novartis Investigative Site

Lutherville, Maryland, United States, 21093

United States, Massachusetts

Novartis Investigative Site

Foxboro, Massachusetts, United States, 02035

Novartis Investigative Site

Lexington, Massachusetts, United States, 02421

Novartis Investigative Site

Wellesley, Massachusetts, United States, 02481

United States, Michigan

Novartis Investigative Site

Ann Arbor, Michigan, United States, 48109

Novartis Investigative Site

Owosso, Michigan, United States, 48867

United States, Minnesota

Novartis Investigative Site

Golden Valley, Minnesota, United States, 55422

United States, Missouri

Novartis Investigative Site

Kansas City, Missouri, United States, 64111

Novartis Investigative Site

Saint Louis, Missouri, United States, 63131

United States, Nevada

Novartis Investigative Site

Las Vegas, Nevada, United States, 89106

United States, New Jersey

Novartis Investigative Site

Fair Lawn, New Jersey, United States, 07410

Novartis Investigative Site

Livingston, New Jersey, United States, 07039

United States, New York

Novartis Investigative Site

Patchogue, New York, United States, 11772

Novartis Investigative Site

Plainview, New York, United States, 11803

United States, North Carolina

Novartis Investigative Site

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

United States, Ohio

Novartis Investigative Site

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

United States, Oklahoma

Novartis Investigative Site

Oklahoma City, Oklahoma, United States, 73102

Novartis Investigative Site

Oklahoma City, Oklahoma, United States, 73104

United States, Oregon

Novartis Investigative Site

Portland, Oregon, United States, 97225

United States, Pennsylvania

Novartis Investigative Site

Philadelphia, Pennsylvania, United States, 19140

United States, South Carolina

Novartis Investigative Site

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

United States, Tennessee

Novartis Investigative Site

Knoxville, Tennessee, United States, 37922

Novartis Investigative Site

Nashville, Tennessee, United States, 37215

United States, Texas

Novartis Investigative Site

Dallas, Texas, United States, 75246

Novartis Investigative Site

San Antonio, Texas, United States, 78258

United States, Virginia

Novartis Investigative Site

Falls Church, Virginia, United States, 22043

Novartis Investigative Site

Vienna, Virginia, United States, 22182

United States, Washington

Novartis Investigative Site

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

United States, West Virginia

Novartis Investigative Site

Huntington, West Virginia, United States, 25701

United States, Wisconsin

Novartis Investigative Site

Green Bay, Wisconsin, United States, 54311

Novartis Investigative Site

Milwaukee, Wisconsin, United States, 53215

Novartis Investigative Site

Neenah, Wisconsin, United States, 54956

Sponsors and Collaborators

Novartis Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):

Study Protocol  [PDF] June 16, 2017

Statistical Analysis Plan  [PDF] September 20, 2019

More Information

Additional Information:

A Plain Language Trial Summary is available on novartisclinicaltrials.com 

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03257358
• Other Study ID Numbers: CFTY720DUS40
• First Posted: August 22, 2017
• Results First Posted: July 21, 2020
• Last Update Posted: October 7, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

• URL: https://www.clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Relapsing Multiple Sclerosis; RMS; Relapsing Multiple Sclerosis (RMS); Multiple Sclerosis; MS; Multiple Sclerosis (MS); Fingolimod; FLUENT; Immune Phenotype; adult; FTY720

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Fingolimod Hydrochloride; Sphingosine 1 Phosphate Receptor Modulators; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs