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

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: NCT03257358
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE August 22, 2017
Results First Submitted Date  ICMJE June 26, 2020
Results First Posted Date  ICMJE July 21, 2020
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE September 19, 2017
Actual Primary Completion Date March 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • Change in CD4+ and CD8+ naïve T-cells, central memory T-cells, and effector memory T-cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.
  • Change in CD4+ Th1, Th2, and Th17 cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.
  • Change in naïve B-cells, memory B-cells, and regulatory B-cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.
  • Change in monocytes, neutrophils, and NK cells from baseline to Month 6. [ Time Frame: Baseline to Month 6 ]
    Blood samples will be collected to assess this outcome.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change From Baseline in T2 Lesion Burden [ Time Frame: Baseline to Month 12 ]
  • Change From Baseline for New Gd-Enhancing T1 Lesion Count [ Time Frame: Baseline to Month 12 ]
  • Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) [ Time Frame: Baseline to Month 6 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • Change in anti-JCV antibody status (+ or -) / index from baseline to Months 3, 6, and 12. [ Time Frame: Baseline to Months 3, 6, and 12 ]
    Blood samples will be collected to assess this outcome.
  • Association of change in anti-JCV antibody status/index and change in CD4+ and CD8+ naïve T-cells, central memory T-cells, and effector memory T-cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.
  • Association of change in anti-JCV antibody status/index and change in CD4+ Th1, Th2, and Th17 cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.
  • Association of change in anti-JCV antibody status/index and change in naïve B-cells, memory B-cells, and regulatory B-cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.
  • Association of change in anti-JCV antibody status/index and change in monocytes, neutrophils and NK cells from baseline to Months 3 and 12. [ Time Frame: Baseline to Months 3 and 12 ]
    Blood samples will be collected to assess this outcome.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Official Title  ICMJE 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]
Brief Summary A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE Drug: Fingolimod
Commercially available 0.5mg hard capsules, taken orally once per day
Study Arms  ICMJE
  • Cohort 1
    RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
    Intervention: Drug: Fingolimod
  • Cohort 2
    RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
    Intervention: Drug: Fingolimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2020)
382
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2017)
400
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date March 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03257358
Other Study ID Numbers  ICMJE CFTY720DUS40
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP