Who is sponsoring NCT02373098?

NCT02373098 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02373098?

Interventions in NCT02373098: Fingolimod 0.5 mg.

What condition does NCT02373098 study?

NCT02373098 studies Relapsing Remitting Multiple Sclerosis.

Is NCT02373098 still recruiting?

NCT02373098 is currently completed. Last updated 30 September 2019.

Are results published for NCT02373098?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-30 · How we verify

NCT02373098

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fingolimod Effect on Cytokine and Chemokine Levels

Completed Phase 4 Results posted Last updated 30 September 2019

What this trial tests

Phase 4 trial testing Fingolimod 0.5 mg in Relapsing Remitting Multiple Sclerosis in 126 participants. Completed in 18 January 2017.

Timeline

31 March 2015

Primary endpoint
18 January 2017

18 January 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	31 March 2015
Primary completion	18 January 2017
Estimated completion	18 January 2017
Sites	3 locations across Turkey (Türkiye)

Drugs / interventions tested

Fingolimod 0.5 mg — full drug profile →

Conditions studied

Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA Primary · Baseline

Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.

CCL5 (RANTES)

Group	Value	95% CI
Healthy Controls	212.26	± 22.48
FTY720	404.31	± 55.189

IL-17A

Group	Value	95% CI
Healthy Controls	1.15	± 0.03
FTY720	1.06	± 0.029

CXCL13

Group	Value	95% CI
Healthy Controls	110.8	± 22.3
FTY720	139.68	± 46.631

IL6

Group	Value	95% CI
Healthy Controls	0.88	± 0.324
FTY720	66.53	± 65.411

IL8

Group	Value	95% CI
Healthy Controls	3.25	± 0.47
FTY720	3.57	± 0.553

IL13

Group	Value	95% CI
Healthy Controls	0.49	± 0.331
FTY720	0.3	± 0.15

IL23

Group	Value	95% CI
Healthy Controls	1.29	± 0.552
FTY720	3.04	± 0.924

VLA4

Group	Value	95% CI
Healthy Controls	1.17	± 0.396
FTY720	0.58	± 0.201

Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients Primary · Baseline

baseline peripheral blood flow cytometric analysis in study participants

CD3 abs

Group	Value	95% CI
Healthy Controls	2048.14	± 263.209
FTY720	1610.94	± 126.071

CD19 abs

Group	Value	95% CI
Healthy Controls	311.63	± 57.592
FTY720	327.63	± 44.421

NK abs

Group	Value	95% CI
Healthy Controls	281.33	± 39.106
FTY720	623.57	± 394.837

NKT abs

Group	Value	95% CI
Healthy Controls	135.86	± 16.627
FTY720	104.36	± 15.080

Hi CD16CD56 abs

Group	Value	95% CI
Healthy Controls	26.64	± 4.399
FTY720	20.44	± 3.506

CD4CD25 (CD3 gate)

Group	Value	95% CI
Healthy Controls	26.08	± 3.159
FTY720	27.08	± 1.251

Hi CD4CD25 (CD3 gate)

Group	Value	95% CI
Healthy Controls	2.83	± 0.383
FTY720	3.33	± 0.253

Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits Secondary · Baseline, month 3, month 6

Change of serum cytokine and chemokine levels measured by ELISA in RRMS patients treated with fingolimod between visits

CXCL13=BLC

Group	Value	95% CI
Visit 1	139.68	± 46.631
Visit 2	105.42	± 20.61
Visit 3	105.86	± 22.053

IL6

Group	Value	95% CI
Visit 1	66.53	± 65.411
Visit 2	49.98	± 49.263
Visit 3	149.62	± 144.622

IL8

Group	Value	95% CI
Visit 1	3.57	± 0.553
Visit 2	3.84	± 0.482
Visit 3	4.29	± 0.541

IL13

Group	Value	95% CI
Visit 1	0.3	± 0.15
Visit 2	0.35	± 0.208
Visit 3	0.48	± 0.289

CCL5= RANTES

Group	Value	95% CI
Visit 1	404.31	± 55.189
Visit 2	384.12	± 52.649
Visit 3	480.34	± 63.874

IL23

Group	Value	95% CI
Visit 1	3.04	± 0.924
Visit 2	2.01	± 0.629
Visit 3	2.15	± 0.699

VLA4

Group	Value	95% CI
Visit 1	0.58	± 0.201
Visit 2	0.76	± 0.356
Visit 3	0.82	± 0.36

CXCL10=IP-10 (CXCR3 ligand)

Group	Value	95% CI
Visit 1	18.18	± 2.405
Visit 2	18.46	± 2.356
Visit 3	20.54	± 3.008

Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients Secondary · 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

CD3 abs

Group	Value	95% CI
Healthy Controls	2048.14	± 263.209
Visit 1	1610.94	± 126.071
Visit 2	339.74	± 43.44
Visit 3	314.75	± 30.15

CD19 abs

Group	Value	95% CI
Healthy Controls	311.63	± 57.592
Visit 1	327.63	± 44.421
Visit 2	32.9	± 5.347
Visit 3	26.56	± 2.879

NK abs

Group	Value	95% CI
Healthy Controls	281.33	± 39.106
Visit 1	623.57	± 394.837
Visit 2	203.66	± 30.487
Visit 3	181.97	± 20.715

NKT abs

Group	Value	95% CI
Healthy Controls	135.86	± 16.627
Visit 1	104.36	± 15.08
Visit 2	88.45	± 12.725
Visit 3	88.98	± 11.046

Hi CD16CD56 abs

Group	Value	95% CI
Healthy Controls	26.64	± 4.399
Visit 1	20.44	± 3.506
Visit 2	29.35	± 8.73
Visit 3	30.04	± 6.59

CD4CD25 (CD3 gate)

Group	Value	95% CI
Healthy Controls	26.08	± 3.159
Visit 1	27.03	± 1.251
Visit 2	9.24	± 1.407
Visit 3	9.22	± 1.399

Hi CD4CD25 (CD3 gate)

Group	Value	95% CI
Healthy Controls	2.83	± 0.383
Visit 1	3.33	± 0.253
Visit 2	2.03	± 0.302
Visit 3	1.77	± 0.267

Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline Primary · Baseline

Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.

CD3 %

Group	Value	95% CI
Healthy Controls	76.52	± 1.494
FTY720	71.92	± 1.134

CD19 %

Group	Value	95% CI
Healthy Controls	11.57	± 1.018
FTY720	13.72	± 1.336

NK %

Group	Value	95% CI
Healthy Controls	11.04	± 1.328
FTY720	10.17	± 1.169

NKT %

Group	Value	95% CI
Healthy Controls	5.65	± 0.855
FTY720	5.19	± 0.766

Hi CD16CD56 %

Group	Value	95% CI
Healthy Controls	1.05	± 0.183
FTY720	0.93	± 0.145

CD3CD4 % (Lymphogate)

Group	Value	95% CI
Healthy Controls	41.19	± 2.483
FTY720	44.91	± 1.321

CD3CD8 % (Lymphogate)

Group	Value	95% CI
Healthy Controls	23.23	± 2.175
FTY720	22.91	± 1.188

CD3CD4 % (CD3 gate)

Group	Value	95% CI
Healthy Controls	57.38	± 2.722
FTY720	62.99	± 1.446

Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients Secondary · 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.

CD3CD4 (Lymphogate)

Group	Value	95% CI
Healthy Controls	41.19	± 2.483
Visit 1	44.91	± 1.321
Visit 2	13.64	± 1.712
Visit 3	13.9	± 1.522

CD3CD8 (Lymphogate)

Group	Value	95% CI
Healthy Controls	23.23	± 2.175
Visit 1	22.91	± 1.188
Visit 2	32.93	± 1.967
Visit 3	32.22	± 2.169

CD3CD4 (CD3 gate)

Group	Value	95% CI
Healthy Controls	57.38	± 2.722
Visit 1	62.99	± 1.446
Visit 2	23.26	± 2.726
Visit 3	24	± 2.788

CD3CD8 (CD3 gate)

Group	Value	95% CI
Healthy Controls	35.11	± 2.305
Visit 1	31.2	± 1.351
Visit 2	59.52	± 2.534
Visit 3	59.66	± 2.642

CD4+IFNg+ (in CD4+)

Group	Value	95% CI
Healthy Controls	7.42	± 1.994
Visit 1	3.61	± 1.037
Visit 2	7.85	± 2.197
Visit 3	13.97	± 2.972

CD4+IL17+ (in CD4+)

Group	Value	95% CI
Healthy Controls	1.23	± 0.173
Visit 1	1.27	± 0.298
Visit 2	1.26	± 0.224
Visit 3	2.02	± 0.342

CD8+IFNg+ (in CD8+)

Group	Value	95% CI
Healthy Controls	16.45	± 3.896
Visit 1	5.47	± 2.463
Visit 2	5.73	± 1.968
Visit 3	14.7	± 3.834

CD8+IL17+ (in CD8+)

Group	Value	95% CI
Healthy Controls	1.71	± 0.636
Visit 1	4.2	± 0.923
Visit 2	9.22	± 3.105
Visit 3	2.23	± 0.505

Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients Secondary · 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

CD3 %

Group	Value	95% CI
Healthy Controls	76.52	± 1.494
Visit 1	71.92	± 1.134
Visit 2	57.61	± 2.401
Visit 3	59.29	± 2.318

CD19 %

Group	Value	95% CI
Healthy Controls	11.57	± 0.018
Visit 1	13.72	± 1.336
Visit 2	6.13	± 0.847
Visit 3	5.14	± 0.427

NK %

Group	Value	95% CI
Healthy Controls	0.427	± 1.328
Visit 1	10.17	± 1.169
Visit 2	34.48	± 2.758
Visit 3	33.91	± 2.238

NKT %

Group	Value	95% CI
Healthy Controls	5.65	± 0.855
Visit 1	5.19	± 0.766
Visit 2	15.55	± 1.726
Visit 3	17.66	± 1.985

Hi CD16CD56 %

Group	Value	95% CI
Healthy Controls	1.05	± 0.183
Visit 1	0.93	± 0.145
Visit 2	5.29	± 1.296
Visit 3	6.20	± 1.423

CD8+IL4+ % (in CD8+)

Group	Value	95% CI
Healthy Controls	5.64	± 3.74
Visit 1	1.87	± 0.538
Visit 2	3.13	± 0.964
Visit 3	1.91	± 1.225

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Visit until 30 days after Last Patient Last Visit) up to approximately 2 years.. Reporting threshold: 0.0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fingolimod 0.5 mg

Serious: 3/66 (5%)

Deaths: 0/66

All Patients

Serious: 3/66 (5%)

Deaths: 0/66

Serious adverse events (2 terms)

Reaction	System	Fingolimod 0.5 mg	All Patients
Sinus bradycardia	Cardiac disorders	—	—
Herpes zoster	Infections and infestations	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Fingolimod 0.5 mg	All Patients
Influenza	Infections and infestations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Lymphocyte count decreased	Investigations	—	—
White blood cell count decreased	Investigations	—	—
Headache	Nervous system disorders	—	—
Muscle contractions involuntary	Nervous system disorders	—	—

Most-reported serious reactions: Sinus bradycardia, Herpes zoster.

Data from ClinicalTrials.gov NCT02373098 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Fingolimod 0.5 mg

Trials testing the same drug.

NCT04280588 — Fingolimod in COVID-19 · Phase 2 · withdrawn

Other recruiting trials for Relapsing Remitting Multiple Sclerosis

Currently open trials in the same condition.

NCT06796504 — The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study · NA · recruiting
NCT05949580 — Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple · recruiting
NCT06282081 — Serum Neurofilament Light in Multiple Sclerosis · active not recruiting
NCT05327322 — Functional Outcomes From Diets in Multiple Sclerosis · NA · active not recruiting
NCT05171972 — Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02373098 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02373098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing