FLUENT
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Results by group
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 404.4 cells/uL | 273.56 (Standard Deviation) | 163 |
| Cohort 2 | 3.4 cells/uL | 20.69 (Standard Deviation) | 217 |
| Cohort 1 | 7.6 cells/uL | 38.04 (Standard Deviation) | 163 |
| Cohort 2 | 4.8 cells/uL | 23.52 (Standard Deviation) | 217 |
| Cohort 1 | -411.4 cells/uL | 273.31 (Standard Deviation) | 163 |
| Cohort 2 | 0.8 cells/uL | 25.12 (Standard Deviation) | 217 |
least squares mean -413.4 (95% CI -422.7–-404.)
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 374.6 cells/uL | 216.36 (Standard Deviation) | 163 |
| Cohort 2 | 16.3 cells/uL | 45.11 (Standard Deviation) | 217 |
| Cohort 1 | 19.6 cells/uL | 58.77 (Standard Deviation) | 163 |
| Cohort 2 | 18.3 cells/uL | 42.89 (Standard Deviation) | 217 |
| Cohort 1 | -368.9 cells/uL | 218.4 (Standard Deviation) | 163 |
| Cohort 2 | 1.1 cells/uL | 51.29 (Standard Deviation) | 217 |
least squares mean -368.7 (95% CI -382.8–354.7)
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 74.3 cells/uL | 43.56 (Standard Deviation) | 163 |
| Cohort 2 | 22.8 cells/uL | 41.21 (Standard Deviation) | 217 |
| Cohort 1 | 18.2 cells/uL | 23 (Standard Deviation) | 163 |
| Cohort 2 | 21.7 cells/uL | 33.28 (Standard Deviation) | 217 |
| Cohort 1 | -51.5 cells/uL | 36.24 (Standard Deviation) | 163 |
| Cohort 2 | -2.0 cells/uL | 31.86 (Standard Deviation) | 217 |
least squares mean -52.1 (95% CI -57.2–-46.9)
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 53.8 cells/uL | 38.29 (Standard Deviation) | 163 |
| Cohort 2 | 11.1 cells/uL | 31.9 (Standard Deviation) | 217 |
| Cohort 1 | 7.6 cells/uL | 15.12 (Standard Deviation) | 163 |
| Cohort 2 | 11.7 cells/uL | 33.33 (Standard Deviation) | 217 |
| Cohort 1 | -43.6 cells/uL | 32.51 (Standard Deviation) | 163 |
| Cohort 2 | -0.7 cells/uL | 14.38 (Standard Deviation) | 217 |
least squares mean -43.6 (95% CI -46.9–-40.3)
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 35.9 cells/uL | 30.06 (Standard Deviation) | 163 |
| Cohort 2 | 1.1 cells/uL | 4.01 (Standard Deviation) | 217 |
| Cohort 1 | 1.7 cells/uL | 4.17 (Standard Deviation) | 163 |
| Cohort 2 | 1.6 cells/uL | 5.55 (Standard Deviation) | 217 |
| Cohort 1 | -36.1 cells/uL | 32.42 (Standard Deviation) | 163 |
| Cohort 2 | 0.5 cells/uL | 5.28 (Standard Deviation) | 217 |
least squares mean -36.3 (95% CI -37.2–-35.3)
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 55.5 cells/uL | 36.6 (Standard Deviation) | 163 |
| Cohort 2 | 2.4 cells/uL | 5.96 (Standard Deviation) | 217 |
| Cohort 1 | 3.1 cells/uL | 8.38 (Standard Deviation) | 163 |
| Cohort 2 | 2.8 cells/uL | 6.91 (Standard Deviation) | 217 |
| Cohort 1 | -53.2 cells/uL | 39.01 (Standard Deviation) | 163 |
| Cohort 2 | 0.5 cells/uL | 6.77 (Standard Deviation) | 217 |
least squares mean -53.2 (95% CI -55.1–-51.3)
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 150.9 cells/uL | 119.48 (Standard Deviation) | 163 |
| Cohort 2 | 1.8 cells/uL | 8.87 (Standard Deviation) | 217 |
| Cohort 1 | 4.2 cells/uL | 22 (Standard Deviation) | 163 |
| Cohort 2 | 3.3 cells/uL | 15.84 (Standard Deviation) | 217 |
| Cohort 1 | -139.3 cells/uL | 113.25 (Standard Deviation) | 163 |
| Cohort 2 | 1.2 cells/uL | 14.89 (Standard Deviation) | 217 |
least squares mean -140.4 (95% CI -145.8–-135.0)
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 93.1 cells/uL | 75.22 (Standard Deviation) | 163 |
| Cohort 2 | 5.6 cells/uL | 14.85 (Standard Deviation) | 217 |
| Cohort 1 | 5.9 cells/uL | 16.42 (Standard Deviation) | 163 |
| Cohort 2 | 6.1 cells/uL | 12.97 (Standard Deviation) | 217 |
| Cohort 1 | -85.2 cells/uL | 67.95 (Standard Deviation) | 163 |
| Cohort 2 | 0.0 cells/uL | 15.92 (Standard Deviation) | 217 |
least squares mean -85.2 (95% CI -89.0–-81.4)
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 108.2 cells/uL | 93.28 (Standard Deviation) | 163 |
| Cohort 2 | 63.8 cells/uL | 115.28 (Standard Deviation) | 217 |
| Cohort 1 | 55.4 cells/uL | 102.88 (Standard Deviation) | 163 |
| Cohort 2 | 52.6 cells/uL | 40.76 (Standard Deviation) | 217 |
| Cohort 1 | -40.6 cells/uL | 103.03 (Standard Deviation) | 163 |
| Cohort 2 | -12.5 cells/uL | 116.16 (Standard Deviation) | 217 |
least squares mean -27.9 (95% CI -51.1–-4.8)
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 201.1 cells/uL | 134.16 (Standard Deviation) | 163 |
| Cohort 2 | 18.1 cells/uL | 33.79 (Standard Deviation) | 217 |
| Cohort 1 | 15.0 cells/uL | 10.5 (Standard Deviation) | 163 |
| Cohort 2 | 17.8 cells/uL | 19.99 (Standard Deviation) | 217 |
| Cohort 1 | -181.4 cells/uL | 125.71 (Standard Deviation) | 163 |
| Cohort 2 | -0.2 cells/uL | 36.61 (Standard Deviation) | 217 |
least squares mean -181.2 (95% CI -183.3–-179.0)
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 61.8 cells/uL | 74.29 (Standard Deviation) | 163 |
| Cohort 2 | 3.3 cells/uL | 22.58 (Standard Deviation) | 217 |
| Cohort 1 | 3.8 cells/uL | 6.24 (Standard Deviation) | 163 |
| Cohort 2 | 4.0 cells/uL | 21.18 (Standard Deviation) | 217 |
| Cohort 1 | -55.1 cells/uL | 74.36 (Standard Deviation) | 163 |
| Cohort 2 | 0.3 cells/uL | 6.4 (Standard Deviation) | 217 |
least squares mean -55.2 (95% CI -56.5–-53.9)
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 12.3 cells/uL | 12.88 (Standard Deviation) | 163 |
| Cohort 2 | 5.3 cells/uL | 7.66 (Standard Deviation) | 217 |
| Cohort 1 | 4.8 cells/uL | 3.92 (Standard Deviation) | 163 |
| Cohort 2 | 6.1 cells/uL | 5.16 (Standard Deviation) | 217 |
| Cohort 1 | -7.4 cells/uL | 10.64 (Standard Deviation) | 163 |
| Cohort 2 | 0.9 cells/uL | 8.15 (Standard Deviation) | 217 |
least squares mean -7.2 (95% CI -8.0–-6.4)
Change From Baseline to Month 6 in Monocytes (CD14+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 329.6 cells/uL | 167.52 (Standard Deviation) | 163 |
| Cohort 2 | 251.7 cells/uL | 118.46 (Standard Deviation) | 217 |
| Cohort 1 | 384.7 cells/uL | 148.76 (Standard Deviation) | 163 |
| Cohort 2 | 379.2 cells/uL | 131.42 (Standard Deviation) | 217 |
| Cohort 1 | 66.1 cells/uL | 139.24 (Standard Deviation) | 163 |
| Cohort 2 | 123.1 cells/uL | 123.85 (Standard Deviation) | 217 |
least squares mean 69.4 (95% CI 42.1–96.7)
Change From Baseline to Month 6 in Neutrophils (CD16+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 4041.4 cells/uL | 1576.73 (Standard Deviation) | 163 |
| Cohort 2 | 3717.9 cells/uL | 1552.87 (Standard Deviation) | 217 |
| Cohort 1 | 3505.4 cells/uL | 1512.81 (Standard Deviation) | 163 |
| Cohort 2 | 3312.6 cells/uL | 1311.04 (Standard Deviation) | 217 |
| Cohort 1 | -586.0 cells/uL | 1463.26 (Standard Deviation) | 163 |
| Cohort 2 | -439.6 cells/uL | 1274.8 (Standard Deviation) | 217 |
least squares mean -782.6 (95% CI -1058.2–-507.1)
Change From Baseline to Month 6 in NK Cells (CD56+)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 166.4 cells/uL | 98.23 (Standard Deviation) | 163 |
| Cohort 2 | 181.0 cells/uL | 113.95 (Standard Deviation) | 217 |
| Cohort 1 | 133.6 cells/uL | 83.41 (Standard Deviation) | 163 |
| Cohort 2 | 154.5 cells/uL | 88.99 (Standard Deviation) | 217 |
| Cohort 1 | -29.4 cells/uL | 76.42 (Standard Deviation) | 163 |
| Cohort 2 | -28.0 cells/uL | 81.73 (Standard Deviation) | 217 |
least squares mean -33.3 (95% CI -48.2–-18.5)
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 936.3 cells/uL | 443.31 (Standard Deviation) | 163 |
| Cohort 2 | 64.4 cells/uL | 122.56 (Standard Deviation) | 217 |
| Cohort 1 | 53.4 cells/uL | 114.61 (Standard Deviation) | 163 |
| Cohort 2 | 71.3 cells/uL | 112.5 (Standard Deviation) | 217 |
| Cohort 1 | -884.1 cells/uL | 440.65 (Standard Deviation) | 163 |
| Cohort 2 | 1.4 cells/uL | 105.17 (Standard Deviation) | 217 |
least squares mean -888.7 (95% CI -914.6–-862.7)
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 49.40 cells/uL | 10.115 (Standard Deviation) | 163 |
| Cohort 2 | 11.95 cells/uL | 12.637 (Standard Deviation) | 217 |
| Cohort 1 | 11.08 cells/uL | 9.875 (Standard Deviation) | 163 |
| Cohort 2 | 12.82 cells/uL | 13.687 (Standard Deviation) | 217 |
| Cohort 1 | -39.09 cells/uL | 12.052 (Standard Deviation) | 163 |
| Cohort 2 | 0.32 cells/uL | 6.119 (Standard Deviation) | 217 |
least squares mean -39.50 (95% CI -41.59–-37.42)
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 419.9 cells/uL | 257.71 (Standard Deviation) | 163 |
| Cohort 2 | 124.6 cells/uL | 213.41 (Standard Deviation) | 217 |
| Cohort 1 | 120.1 cells/uL | 148.82 (Standard Deviation) | 163 |
| Cohort 2 | 116.8 cells/uL | 101.44 (Standard Deviation) | 217 |
| Cohort 1 | -266.2 cells/uL | 209.45 (Standard Deviation) | 163 |
| Cohort 2 | -13.5 cells/uL | 205.59 (Standard Deviation) | 217 |
least squares mean -248.9 (95% CI -278.7–-219.2)
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 21.86 cells/uL | 7.852 (Standard Deviation) | 163 |
| Cohort 2 | 25.25 cells/uL | 14.406 (Standard Deviation) | 217 |
| Cohort 1 | 25.33 cells/uL | 14.998 (Standard Deviation) | 163 |
| Cohort 2 | 24.99 cells/uL | 13.863 (Standard Deviation) | 217 |
| Cohort 1 | 4.63 cells/uL | 11.327 (Standard Deviation) | 163 |
| Cohort 2 | -0.39 cells/uL | 4.528 (Standard Deviation) | 217 |
least squares mean 5.60 (95% CI 3.13–8.08)
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 259.7 cells/uL | 167.94 (Standard Deviation) | 163 |
| Cohort 2 | 21.4 cells/uL | 45.19 (Standard Deviation) | 217 |
| Cohort 1 | 19.5 cells/uL | 15.91 (Standard Deviation) | 163 |
| Cohort 2 | 21.8 cells/uL | 34.75 (Standard Deviation) | 217 |
| Cohort 1 | -231.3 cells/uL | 153.49 (Standard Deviation) | 163 |
| Cohort 2 | 0.1 cells/uL | 40.66 (Standard Deviation) | 217 |
least squares mean -231.0 (95% CI -234.5–-227.6)
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
Baseline to Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 13.97 cells/uL | 7.245 (Standard Deviation) | 163 |
| Cohort 2 | 4.81 cells/uL | 5.294 (Standard Deviation) | 217 |
| Cohort 1 | 5.38 cells/uL | 4.368 (Standard Deviation) | 163 |
| Cohort 2 | 4.83 cells/uL | 5.236 (Standard Deviation) | 217 |
| Cohort 1 | -8.53 cells/uL | 6.723 (Standard Deviation) | 163 |
| Cohort 2 | 0.23 cells/uL | 3.027 (Standard Deviation) | 217 |
least squares mean -8.30 (95% CI -9.21–-7.40)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cohort 1 | 163 | 9 (5.5%) | 0 |
| Cohort 2 | 217 | 12 (5.5%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 6
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 6
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 6
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 6
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
Baseline to Month 6
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Monocytes (CD14+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Neutrophils (CD16+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in NK Cells (CD56+)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD4+ Absolute Cell Count
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD4+ Differential Cell Count
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD8+ Absolute Cell Count
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD19+ Absolute Cell Count
Baseline to Month 6
Blood or spinal fluid markersImmune responseChange From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
Baseline to Month 6
Blood or spinal fluid markersImmune response
Other measures (27)
Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)
Baseline to Month 12
Blood or spinal fluid markersImmune responseChange From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 12
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 12
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)
Baseline to Month 12
Blood or spinal fluid markersImmune responseChange From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)
Baseline to Month 12
Blood or spinal fluid markersImmune responseChange From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)
Baseline to Month 12
Blood or spinal fluid markersImmune responseChange From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)
Baseline to Month 12
Blood or spinal fluid markersImmune responseChange From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline to Month 12
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline to Month 12
Blood or spinal fluid markersThinking and memoryImmune responseChange From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)
Baseline to Month 12
Blood or spinal fluid markersImmune response
Who could take part
Relapsing MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod
Papers
Loading reviews and guidelines…
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History
Started
Sept 2017
Main results due
Mar 2019
Finished
Jun 2019
Results posted
Jul 2020
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