Trial · NCT02373098

Fingolimod Effect on Cytokine and Chemokine Levels

NCT02373098, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fingolimod Effect on Cytokine and Chemokine Levels. Trials, record NCT02373098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02373098

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fingolimod Effect on Cytokine and Chemokine Levels
NCT number: NCT02373098
Status: Completed
Phases: Phase 4
Enrollment: 126 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Relapsing Remitting Multiple Sclerosis
Interventions: Fingolimod 0.5 mg
First posted: 2015-02-26
Last updated: 2019-09-30
Results first posted: 2019-09-30

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Baseline	Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.
Primary	Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients	Baseline	baseline peripheral blood flow cytometric analysis in study participants
Primary	Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline	Baseline	Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.
Secondary	Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits	Baseline, month 3, month 6	Change of serum cytokine and chemokine levels measured by ELISA in RRMS patients treated with fingolimod between visits
Secondary	Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Peripheral blood chemokine cytokine levels measured by flow cytometry during fingolimod treatment in healthy controls at baseline and in RRMS patients between visits
Secondary	Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Peripheral blood chemokine cytokine levels measured by flow cytometry at baseline and between visits during fingolimod treatment. Absolute counts of the cells were calculated according to the absolute lymphocyte counts and the percentages of cells. This allowed for a clear determination of cell counts and thus increased the reliability of the results.
Secondary	Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Peripheral blood chemokine cytokine levels measured by flow cytometry in healthy controls at baseline and in RRMS patients between visits during fingolimod treatment

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Baseline	Intent to treat	pg/ml	MEAN
PRIMARY	Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients	Baseline	Analysis was done in the healthy volunteers and RRMS patients.	absolute cell count	MEAN
SECONDARY	Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits	Baseline, month 3, month 6	Intent to treat	pg/ml	MEAN
SECONDARY	Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Intent to treat. Data analyzed in RRMS patients.	pg/ml	MEAN
PRIMARY	Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline	Baseline	Analysis was done in the healthy volunteers and RRMS patients.	Percent of cells	MEAN
SECONDARY	Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Intent to treat. Data analyzed in RRMS patients.	absolute cell count	MEAN
SECONDARY	Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	Baseline, Month 3, Month 6	Intent to treat. Data analyzed in RRMS patients.	percent of cell count	MEAN

Source ClinicalTrials.gov

Results by group275

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Healthy Controls	CCL5 (RANTES)	212.26	Standard Error 22.48	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	FTY720	CCL5 (RANTES)	404.31	Standard Error 55.189	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Healthy Controls	IL-17A	1.15	Standard Error 0.03	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	FTY720	IL-17A	1.06	Standard Error 0.029	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Healthy Controls	CXCL13	110.8	Standard Error 22.3	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	FTY720	CXCL13	139.68	Standard Error 46.631	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Healthy Controls	IL6	0.88	Standard Error 0.324	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	FTY720	IL6	66.53	Standard Error 65.411	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Healthy Controls	IL8	3.25	Standard Error 0.47	pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	FTY720	IL8	3.57	Standard Error 0.553	pg/ml

1 to 10 of 275Source ClinicalTrials.gov

See all 275 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FTY720	66
Overall Study	STARTED	Healthy Volunteers	60
Overall Study	COMPLETED	FTY720	54
Overall Study	COMPLETED	Healthy Volunteers	60
Overall Study	NOT COMPLETED	FTY720	12
Overall Study	NOT COMPLETED	Healthy Volunteers	0

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Influenza	Infections and infestations	Fingolimod 0.5 mg	2	66
other	Influenza	Infections and infestations	All Patients	2	66
other	Gamma-glutamyltransferase increased	Investigations	Fingolimod 0.5 mg	1	66
other	Gamma-glutamyltransferase increased	Investigations	All Patients	1	66
other	Lymphocyte count decreased	Investigations	Fingolimod 0.5 mg	1	66
other	Lymphocyte count decreased	Investigations	All Patients	1	66
other	White blood cell count decreased	Investigations	Fingolimod 0.5 mg	1	66
other	White blood cell count decreased	Investigations	All Patients	1	66
other	Headache	Nervous system disorders	Fingolimod 0.5 mg	1	66
other	Headache	Nervous system disorders	All Patients	1	66

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fingolimod 0.5 mg	0	66
Total, all-cause mortality	All Patients	0	66
Total, other adverse events	Fingolimod 0.5 mg	7	66
Total, other adverse events	All Patients	7	66
Total, serious adverse events	Fingolimod 0.5 mg	3	66
Total, serious adverse events	All Patients	3	66

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fingolimod 0.5 mg vs All Patients: deaths from any cause	Trial comparisons
Fingolimod 0.5 mg vs All Patients: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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