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

NCT03257358 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CFTY720DUS40
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 66

Brief Summary

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

Conditions

Relapsing Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (27)

• Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)

  Baseline to Month 12

• Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)

  Baseline to Month 12

• Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)

  Baseline to Month 12

• Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)

  Baseline to Month 12

• Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)

  Baseline to Month 12

Study Arms (2)

Cohort 1

OTHER

RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day

Drug: Fingolimod

Cohort 2

OTHER

RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years

Drug: Fingolimod

Interventions

Fingolimod DRUG

Commercially available 0.5mg hard capsules, taken orally once per day

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (66)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

Location

Novartis Investigative Site

Cullman, Alabama, 35058, United States

Location

Novartis Investigative Site

Tucson, Arizona, 85718, United States

Location

Novartis Investigative Site

Berkeley, California, 94705, United States

Location

Novartis Investigative Site

Sacramento, California, 95817, United States

Location

Novartis Investigative Site

Colorado Springs, Colorado, 80907, United States

Location

Novartis Investigative Site

Louisville, Colorado, 80027, United States

Location

Novartis Investigative Site

Boca Raton, Florida, 33482, United States

Location

Novartis Investigative Site

Boca Raton, Florida, 33487, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32209, United States

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Novartis Investigative Site

Miami, Florida, 33136, United States

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Novartis Investigative Site

Ocala, Florida, 34471, United States

Location

Novartis Investigative Site

Port Charlotte, Florida, 33952, United States

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Novartis Investigative Site

Sarasota, Florida, 34243, United States

Location

Novartis Investigative Site

Sunrise, Florida, 33351, United States

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Novartis Investigative Site

Vero Beach, Florida, 32960, United States

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Novartis Investigative Site

Savannah, Georgia, 31406, United States

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Novartis Investigative Site

Suwanee, Georgia, 30024, United States

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Novartis Investigative Site

Flossmoor, Illinois, 60422, United States

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Novartis Investigative Site

Kansas City, Kansas, 66160, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40207, United States

Location

Novartis Investigative Site

Lutherville, Maryland, 21093, United States

Location

Novartis Investigative Site

Foxborough, Massachusetts, 02035, United States

Location

Novartis Investigative Site

Lexington, Massachusetts, 02421, United States

Location

Novartis Investigative Site

Wellesley, Massachusetts, 02481, United States

Location

Novartis Investigative Site

Ann Arbor, Michigan, 48109, United States

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Novartis Investigative Site

Owosso, Michigan, 48867, United States

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Novartis Investigative Site

Golden Valley, Minnesota, 55422, United States

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Novartis Investigative Site

Kansas City, Missouri, 64111, United States

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Novartis Investigative Site

St Louis, Missouri, 63131, United States

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Novartis Investigative Site

Las Vegas, Nevada, 89106, United States

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Novartis Investigative Site

Fair Lawn, New Jersey, 07410, United States

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Novartis Investigative Site

Livingston, New Jersey, 07039, United States

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Novartis Investigative Site

Patchogue, New York, 11772, United States

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Novartis Investigative Site

Plainview, New York, 11803, United States

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Novartis Investigative Site

Asheville, North Carolina, 28806, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

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Novartis Investigative Site

Mooresville, North Carolina, 28117, United States

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Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

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Novartis Investigative Site

Winston-Salem, North Carolina, 27103, United States

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Novartis Investigative Site

Cleveland, Ohio, 44195, United States

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Novartis Investigative Site

Dayton, Ohio, 45408, United States

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Novartis Investigative Site

Toledo, Ohio, 43623, United States

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Novartis Investigative Site

Westerville, Ohio, 43081, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73102, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73104, United States

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Novartis Investigative Site

Portland, Oregon, 97225, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, 19140, United States

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Novartis Investigative Site

Greer, South Carolina, 29650, United States

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Novartis Investigative Site

Mt. Pleasant, South Carolina, 29464, United States

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Novartis Investigative Site

Port Royal, South Carolina, 29935, United States

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Novartis Investigative Site

Knoxville, Tennessee, 37922, United States

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Novartis Investigative Site

Nashville, Tennessee, 37215, United States

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Novartis Investigative Site

Dallas, Texas, 75246, United States

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Novartis Investigative Site

San Antonio, Texas, 78258, United States

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Novartis Investigative Site

Falls Church, Virginia, 22043, United States

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Novartis Investigative Site

Vienna, Virginia, 22182, United States

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Novartis Investigative Site

Kirkland, Washington, 98034, United States

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Novartis Investigative Site

Seattle, Washington, 98122, United States

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Novartis Investigative Site

Spokane, Washington, 99202, United States

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Novartis Investigative Site

Tacoma, Washington, 98405, United States

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Novartis Investigative Site

Huntington, West Virginia, 25701, United States

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Novartis Investigative Site

Green Bay, Wisconsin, 54311, United States

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Novartis Investigative Site

Milwaukee, Wisconsin, 53215, United States

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Novartis Investigative Site

Neenah, Wisconsin, 54956, United States

Location

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-cohort, non-randomized, open-label multicenter

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: September 19, 2017
• Primary Completion: March 5, 2019
• Study Completion: June 28, 2019
• Last Updated: October 7, 2021
• Results First Posted: July 21, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (66)