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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 October 2021
Main ID:	NCT03257358
Date of registration:	18/08/2017
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharmaceuticals
Public title:	A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod FLUENT
Scientific 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]
Date of first enrolment:	September 19, 2017
Target sample size:	382
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03257358
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
United States

Contacts

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Fingolimod

Primary Outcome(s)

Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Neutrophils (CD16+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD4+ Differential Cell Count [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Monocytes (CD14+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in NK Cells (CD56+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) [Time Frame: Baseline to Month 6]

Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) [Time Frame: Baseline to Month 6]

Secondary Outcome(s)

Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count [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 in T2 Lesion Burden [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) [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]

Multiple Sclerosis (MS) Relapses During Treatment [Time Frame: Baseline to Month 12]

Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) [Time Frame: Baseline to Month 12]

Change From Baseline in Patient Determined Disease Steps (PDDS) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Neutrophils (CD16+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Monocytes (CD14+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in NK Cells (CD56+) [Time Frame: Baseline to Month 12]

Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) [Time Frame: Baseline to Month 12]

Secondary ID(s)

CFTY720DUS40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	21/07/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT03257358

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