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 )

Tracking Information

• First Submitted Date: August 18, 2017
• First Posted Date: August 22, 2017
• Results First Submitted Date: June 26, 2020
• Results First Posted Date: July 21, 2020
• Last Update Posted Date: October 7, 2021
• Actual Study Start Date: September 19, 2017
• Actual Primary Completion Date: March 5, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
• 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]
• 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: Interventional
• Study Phase: Phase 4

Study Design

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: Relapsing Multiple Sclerosis

Intervention

Drug: Fingolimod

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2020): 382
• Original Estimated Enrollment (submitted: August 18, 2017): 400
• Actual Study Completion Date: June 28, 2019
• Actual Primary Completion Date: March 5, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03257358
• Other Study ID Numbers: 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

• 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

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: October 2021