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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 )

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..

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257358


Locations
Show Show 66 study locations
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

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03257358    
Other Study ID Numbers: CFTY720DUS40
First Posted: August 22, 2017    Key Record Dates
Results First Posted: July 21, 2020
Last Update Posted: July 21, 2020
Last Verified: June 2020
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
FLUENT
Relapsing Multiple Sclerosis
RMS
Relapsing Multiple Sclerosis (RMS)
Multiple Sclerosis
MS
Multiple Sclerosis (MS)
Fingolimod
Immune Phenotype
adult
FTY720
Additional relevant MeSH terms:
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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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs