Fingolimod Effect on Cytokine and Chemokine Levels
Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
What it found
Met its main goal
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.000 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.000 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.001 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.001 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.002 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.004 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.007 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.013 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.013 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.013 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.017 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.017 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.017 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.022 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.026 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.035 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.057 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.069 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.096 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.107 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.121 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.127 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.168 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.171 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.179 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.208 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.209 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.256 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.270 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.283 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.300 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.300 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.356 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.402 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.439 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.449 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.587 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.657 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.662 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.724 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.725 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.727 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.730 | ||
| Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline | 0.787 | ||
| Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients | 0.902 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.911 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 0.934 | ||
| Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA | 1.000 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
Results by group
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Controls | 212.26 pg/ml | 22.48 (Standard Error) | 60 |
| FTY720 | 404.31 pg/ml | 55.189 (Standard Error) | 66 |
| Healthy Controls | 1.15 pg/ml | 0.03 (Standard Error) | 60 |
| FTY720 | 1.06 pg/ml | 0.029 (Standard Error) | 66 |
| Healthy Controls | 110.8 pg/ml | 22.3 (Standard Error) | 60 |
| FTY720 | 139.68 pg/ml | 46.631 (Standard Error) | 66 |
| Healthy Controls | 0.88 pg/ml | 0.324 (Standard Error) | 60 |
| FTY720 | 66.53 pg/ml | 65.411 (Standard Error) | 66 |
| Healthy Controls | 3.25 pg/ml | 0.47 (Standard Error) | 60 |
| FTY720 | 3.57 pg/ml | 0.553 (Standard Error) | 66 |
| Healthy Controls | 0.49 pg/ml | 0.331 (Standard Error) | 60 |
| FTY720 | 0.3 pg/ml | 0.15 (Standard Error) | 66 |
| Healthy Controls | 1.29 pg/ml | 0.552 (Standard Error) | 60 |
| FTY720 | 3.04 pg/ml | 0.924 (Standard Error) | 66 |
| Healthy Controls | 1.17 pg/ml | 0.396 (Standard Error) | 60 |
| FTY720 | 0.58 pg/ml | 0.201 (Standard Error) | 66 |
| Healthy Controls | 16.09 pg/ml | 1.76 (Standard Error) | 60 |
| FTY720 | 18.18 pg/ml | 2.405 (Standard Error) | 66 |
| Healthy Controls | 52.88 pg/ml | 4.281 (Standard Error) | 60 |
| FTY720 | 62.89 pg/ml | 8.42 (Standard Error) | 66 |
| Healthy Controls | 2.02 pg/ml | 0.077 (Standard Error) | 60 |
| FTY720 | 2.36 pg/ml | 0.149 (Standard Error) | 66 |
| Healthy Controls | 1.1 pg/ml | 0.195 (Standard Error) | 60 |
| FTY720 | 1.06 pg/ml | 0.1 (Standard Error) | 66 |
| Healthy Controls | 22.36 pg/ml | 0.581 (Standard Error) | 60 |
| FTY720 | 22.41 pg/ml | 0.547 (Standard Error) | 66 |
p = 0.000
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Controls | 2048.14 absolute cell count | 263.209 (Standard Error) | 60 |
| FTY720 | 1610.94 absolute cell count | 126.071 (Standard Error) | 66 |
| Healthy Controls | 311.63 absolute cell count | 57.592 (Standard Error) | 60 |
| FTY720 | 327.63 absolute cell count | 44.421 (Standard Error) | 66 |
| Healthy Controls | 281.33 absolute cell count | 39.106 (Standard Error) | 60 |
| FTY720 | 623.57 absolute cell count | 394.837 (Standard Error) | 66 |
| Healthy Controls | 135.86 absolute cell count | 16.627 (Standard Error) | 60 |
| FTY720 | 104.36 absolute cell count | 15.08 (Standard Error) | 66 |
| Healthy Controls | 26.64 absolute cell count | 4.399 (Standard Error) | 60 |
| FTY720 | 20.44 absolute cell count | 3.506 (Standard Error) | 66 |
| Healthy Controls | 26.08 absolute cell count | 3.159 (Standard Error) | 60 |
| FTY720 | 27.08 absolute cell count | 1.251 (Standard Error) | 66 |
| Healthy Controls | 2.83 absolute cell count | 0.383 (Standard Error) | 60 |
| FTY720 | 3.33 absolute cell count | 0.253 (Standard Error) | 66 |
p = 0.256
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Healthy Controls | 76.52 Percent of cells | 1.494 (Standard Error) | 60 |
| FTY720 | 71.92 Percent of cells | 1.134 (Standard Error) | 66 |
| Healthy Controls | 11.57 Percent of cells | 1.018 (Standard Error) | 60 |
| FTY720 | 13.72 Percent of cells | 1.336 (Standard Error) | 66 |
| Healthy Controls | 11.04 Percent of cells | 1.328 (Standard Error) | 60 |
| FTY720 | 10.17 Percent of cells | 1.169 (Standard Error) | 66 |
| Healthy Controls | 5.65 Percent of cells | 0.855 (Standard Error) | 60 |
| FTY720 | 5.19 Percent of cells | 0.766 (Standard Error) | 66 |
| Healthy Controls | 1.05 Percent of cells | 0.183 (Standard Error) | 60 |
| FTY720 | 0.93 Percent of cells | 0.145 (Standard Error) | 66 |
| Healthy Controls | 41.19 Percent of cells | 2.483 (Standard Error) | 60 |
| FTY720 | 44.91 Percent of cells | 1.321 (Standard Error) | 66 |
| Healthy Controls | 23.23 Percent of cells | 2.175 (Standard Error) | 60 |
| FTY720 | 22.91 Percent of cells | 1.188 (Standard Error) | 66 |
| Healthy Controls | 57.38 Percent of cells | 2.722 (Standard Error) | 60 |
| FTY720 | 62.99 Percent of cells | 1.446 (Standard Error) | 66 |
| Healthy Controls | 35.11 Percent of cells | 2.305 (Standard Error) | 60 |
| FTY720 | 31.20 Percent of cells | 1.351 (Standard Error) | 66 |
| Healthy Controls | 7.42 Percent of cells | 1.994 (Standard Error) | 60 |
| FTY720 | 3.61 Percent of cells | 1.037 (Standard Error) | 66 |
| Healthy Controls | 1.23 Percent of cells | 0.173 (Standard Error) | 60 |
| FTY720 | 1.27 Percent of cells | 0.298 (Standard Error) | 66 |
| Healthy Controls | 16.45 Percent of cells | 3.896 (Standard Error) | 60 |
| FTY720 | 5.47 Percent of cells | 2.463 (Standard Error) | 66 |
| Healthy Controls | 1.71 Percent of cells | 0.636 (Standard Error) | 60 |
| FTY720 | 4.20 Percent of cells | 0.923 (Standard Error) | 66 |
| Healthy Controls | 7.1 Percent of cells | 1.896 (Standard Error) | 60 |
| FTY720 | 1.98 Percent of cells | 0.469 (Standard Error) | 66 |
| Healthy Controls | 2.35 Percent of cells | 0.264 (Standard Error) | 60 |
| FTY720 | 2.06 Percent of cells | 0.41 (Standard Error) | 66 |
| Healthy Controls | 1.64 Percent of cells | 0.33 (Standard Error) | 60 |
| FTY720 | 0.72 Percent of cells | 0.196 (Standard Error) | 66 |
| Healthy Controls | 1.44 Percent of cells | 0.294 (Standard Error) | 60 |
| FTY720 | 0.96 Percent of cells | 0.41 (Standard Error) | 66 |
| Healthy Controls | 1.31 Percent of cells | 0.31 (Standard Error) | 60 |
| FTY720 | 2.62 Percent of cells | 1.125 (Standard Error) | 66 |
| Healthy Controls | 0.52 Percent of cells | 0.089 (Standard Error) | 60 |
| FTY720 | 0.31 Percent of cells | 0.096 (Standard Error) | 66 |
| Healthy Controls | 5.64 Percent of cells | 3.74 (Standard Error) | 60 |
| FTY720 | 1.87 Percent of cells | 0.538 (Standard Error) | 66 |
| Healthy Controls | 2.57 Percent of cells | 0.228 (Standard Error) | 60 |
| FTY720 | 1.81 Percent of cells | 0.464 (Standard Error) | 66 |
| Healthy Controls | 1.88 Percent of cells | 0.34 (Standard Error) | 60 |
| FTY720 | 0.50 Percent of cells | 0.105 (Standard Error) | 66 |
| Healthy Controls | 46.86 Percent of cells | 4.892 (Standard Error) | 60 |
| FTY720 | 23.72 Percent of cells | 4.707 (Standard Error) | 66 |
| Healthy Controls | 0.22 Percent of cells | 0.109 (Standard Error) | 60 |
| FTY720 | 0.54 Percent of cells | 0.163 (Standard Error) | 66 |
| Healthy Controls | 35 Percent of cells | 4.876 (Standard Error) | 60 |
| FTY720 | 11.78 Percent of cells | 2.679 (Standard Error) | 66 |
| Healthy Controls | 0.14 Percent of cells | 0.087 (Standard Error) | 60 |
| FTY720 | 0.90 Percent of cells | 0.245 (Standard Error) | 66 |
| Healthy Controls | 52.82 Percent of cells | 5.019 (Standard Error) | 60 |
| FTY720 | 23.29 Percent of cells | 4.43 (Standard Error) | 66 |
| Healthy Controls | 5.06 Percent of cells | 4.497 (Standard Error) | 60 |
| FTY720 | 0.59 Percent of cells | 0.221 (Standard Error) | 66 |
p = 0.017
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod 0.5 mg | 66 | 3 (4.5%) | 0 |
| All Patients | 66 | 3 (4.5%) | 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
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
Baseline
Immune responseBaseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
Baseline
Immune responsePercent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
Baseline
Immune response
Other measures (4)
Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits
Baseline, month 3, month 6
Immune responsePeripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Baseline, Month 3, Month 6
Immune responseAbsolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Baseline, Month 3, Month 6
Immune responsePercent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Baseline, Month 3, Month 6
Immune response
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: 1. Written informed consent must be obtained before the beginning of te study 2. Nonresponder RRMS patients 3. Last relapse of the patient should be at least 2 months before study entry. 4. Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry. Key Exclusion Criteria: 1. Patients with secondary progressive MS. 2. Patients with known contraindications for fingolimod treatment. 3. Other coexistent autoimmune diseases 4. Pregnant or nursing (lactating) women
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The main purpose of this study was to measure the serum levels of cytokines and chemokines that are known to increase during multiple sclerosis relapses. Cytokines are a broad and loose category of small proteins that are important in cell signaling. The second purpose of the study was to test the cytokine/chemokine changes measured in the 3rd and 6th months on the efficacy parameters.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2015
Main results due
Jan 2017
Finished
Jan 2017
Results posted
Sept 2019
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