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CompletedNCT02373098Updated Sep 30, 2019Results posted

Fingolimod Effect on Cytokine and Chemokine Levels

A Phase 4 interventional study of Fingolimod 0.5 mg in Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
126
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Relapsing Remitting Multiple Sclerosis

Keywords

  • Fingolimod,cytokine,chemokine,RRMS
03

In context

Multiple Sclerosis, Relapsing-Remitting

615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.

This study's enrollment of 126 is above the median of 72 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    FTY720

    Drug: Fingolimod 0.5 mg

  • No intervention
    Healthy volunteers

    Healthy volunteers with no intervention or drug administered.

Interventions

  • DrugFingolimod 0.5 mg

    66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.

06

What researchers measure

Primary outcomes

  1. Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA

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

    Time frame: Baseline

  2. Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients

    baseline peripheral blood flow cytometric analysis in study participants

    Time frame: Baseline

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

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

    Time frame: Baseline

Secondary outcomes

  1. Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits

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

    Time frame: Baseline, month 3, month 6

  2. Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

    Peripheral blood chemokine cytokine levels measured by flow cytometry during fingolimod treatment in healthy controls at baseline and in RRMS patients between visits

    Time frame: Baseline, Month 3, Month 6

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

    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.

    Time frame: Baseline, Month 3, Month 6

  4. Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

    Peripheral blood chemokine cytokine levels measured by flow cytometry in healthy controls at baseline and in RRMS patients between visits during fingolimod treatment

    Time frame: Baseline, Month 3, Month 6

07

Results

Posted Sep 30, 2019

Participant flow

Participant flow — Overall Study
MilestoneFTY720Healthy Volunteers
Started6660
Completed5460
Not completed120
Withdrew: Lost to follow-up10
Withdrew: Protocol violation30
Withdrew: Withdrawal by subject50
Withdrew: Adverse event30

Outcome measures

PrimaryBaseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA

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

Time frame:
Baseline
Reported as:
Mean · pg/ml
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
pg/mlHealthy ControlsFTY720
CCL5 (RANTES)212.26 ± 22.48404.31 ± 55.189
IL-17A1.15 ± 0.031.06 ± 0.029
CXCL13110.8 ± 22.3139.68 ± 46.631
IL60.88 ± 0.32466.53 ± 65.411
IL83.25 ± 0.473.57 ± 0.553
IL130.49 ± 0.3310.3 ± 0.15
IL231.29 ± 0.5523.04 ± 0.924
VLA41.17 ± 0.3960.58 ± 0.201
CXCL10=IP-10 (CXCR3 ligand)16.09 ± 1.7618.18 ± 2.405
CCL2=MCP-152.88 ± 4.28162.89 ± 8.42
IL42.02 ± 0.0772.36 ± 0.149
TNF alpha1.1 ± 0.1951.06 ± 0.1
IL2222.36 ± 0.58122.41 ± 0.547
Statistical analysis
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.000
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.035
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.911
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 1.000
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.934
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.727
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.179
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.208
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.730
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.725
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.057
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.724
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.662
PrimaryBaseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients

baseline peripheral blood flow cytometric analysis in study participants

Time frame:
Baseline
Reported as:
Mean · absolute cell count
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
absolute cell countHealthy ControlsFTY720
CD3 abs2048.14 ± 263.2091610.94 ± 126.071
CD19 abs311.63 ± 57.592327.63 ± 44.421
NK abs281.33 ± 39.106623.57 ± 394.837
NKT abs135.86 ± 16.627104.36 ± 15.080
Hi CD16CD56 abs26.64 ± 4.39920.44 ± 3.506
CD4CD25 (CD3 gate)26.08 ± 3.15927.08 ± 1.251
Hi CD4CD25 (CD3 gate)2.83 ± 0.3833.33 ± 0.253
Statistical analysis
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.256
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.587
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.300
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.096
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.270
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.902
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.283
SecondarySerum Cytokine and Chemokine Levels inRRMS Patients Between Visits

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

Time frame:
Baseline, month 3, month 6
Reported as:
Mean · pg/ml
Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits
pg/mlVisit 1Visit 2Visit 3
CXCL13=BLC139.68 ± 46.631105.42 ± 20.61105.86 ± 22.053
IL666.53 ± 65.41149.98 ± 49.263149.62 ± 144.622
IL83.57 ± 0.5533.84 ± 0.4824.29 ± 0.541
IL130.3 ± 0.150.35 ± 0.2080.48 ± 0.289
CCL5= RANTES404.31 ± 55.189384.12 ± 52.649480.34 ± 63.874
IL233.04 ± 0.9242.01 ± 0.6292.15 ± 0.699
VLA40.58 ± 0.2010.76 ± 0.3560.82 ± 0.36
CXCL10=IP-10 (CXCR3 ligand)18.18 ± 2.40518.46 ± 2.35620.54 ± 3.008
CCL2=MCP-162.89 ± 8.4274.38 ± 10.01192.73 ± 13.626
IL42.36 ± 0.1491.94 ± 0.0992.12 ± 0.145
IL17A1.06 ± 0.0291.09 ± 0.041.04 ± 0.033
TNF1.06 ± 0.11.26 ± 0.1961.12 ± 0.139
IL2222.41 ± 0.6922.45 ± 0.84322.99 ± 0.739
SecondaryPeripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

Peripheral blood chemokine cytokine levels measured by flow cytometry during fingolimod treatment in healthy controls at baseline and in RRMS patients between visits

Time frame:
Baseline, Month 3, Month 6
Reported as:
Mean · pg/ml
Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
pg/mlHealthy ControlsVisit 1Visit 2Visit 3
CD3 abs2048.14 ± 263.2091610.94 ± 126.071339.74 ± 43.44314.75 ± 30.15
CD19 abs311.63 ± 57.592327.63 ± 44.42132.9 ± 5.34726.56 ± 2.879
NK abs281.33 ± 39.106623.57 ± 394.837203.66 ± 30.487181.97 ± 20.715
NKT abs135.86 ± 16.627104.36 ± 15.0888.45 ± 12.72588.98 ± 11.046
Hi CD16CD56 abs26.64 ± 4.39920.44 ± 3.50629.35 ± 8.7330.04 ± 6.59
CD4CD25 (CD3 gate)26.08 ± 3.15927.03 ± 1.2519.24 ± 1.4079.22 ± 1.399
Hi CD4CD25 (CD3 gate)2.83 ± 0.3833.33 ± 0.2532.03 ± 0.3021.77 ± 0.267
PrimaryPercent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline

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

Time frame:
Baseline
Reported as:
Mean · Percent of cells
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
Percent of cellsHealthy ControlsFTY720
CD3 %76.52 ± 1.49471.92 ± 1.134
CD19 %11.57 ± 1.01813.72 ± 1.336
NK %11.04 ± 1.32810.17 ± 1.169
NKT %5.65 ± 0.8555.19 ± 0.766
Hi CD16CD56 %1.05 ± 0.1830.93 ± 0.145
CD3CD4 % (Lymphogate)41.19 ± 2.48344.91 ± 1.321
CD3CD8 % (Lymphogate)23.23 ± 2.17522.91 ± 1.188
CD3CD4 % (CD3 gate)57.38 ± 2.72262.99 ± 1.446
CD3CD8 % (CD3 gate)35.11 ± 2.30531.20 ± 1.351
CD4+IFNg+ (in CD4+)7.42 ± 1.9943.61 ± 1.037
CD4+IL17+ (in CD4+)1.23 ± 0.1731.27 ± 0.298
CD8+IFNg+ (in CD8+)16.45 ± 3.8965.47 ± 2.463
CD8+IL17+ (in CD8+)1.71 ± 0.6364.20 ± 0.923
IFNg+ (in CD4+CD25+)7.1 ± 1.8961.98 ± 0.469
IL17+ (in CD4+CD25+)2.35 ± 0.2642.06 ± 0.410
CD4+IL10+ (in CD4+)1.64 ± 0.330.72 ± 0.196
CD4+IL4+ (in CD4+)1.44 ± 0.2940.96 ± 0.410
CD4-CD8-IL4+ (in CD4-CD8-)1.31 ± 0.312.62 ± 1.125
CD8+IL10+ (in CD8+)0.52 ± 0.0890.31 ± 0.096
CD8+IL4+ % (in CD8+)5.64 ± 3.741.87 ± 0.538
IL10+ (in CD4+CD25+)2.57 ± 0.2281.81 ± 0.464
IL4+ (in CD4+CD25+)1.88 ± 0.340.50 ± 0.105
CD4+TNFa+ (in CD4+)46.86 ± 4.89223.72 ± 4.707
CD4+IL9+ (in CD4+)0.22 ± 0.1090.54 ± 0.163
CD8+TNFa+ (in CD8+)35 ± 4.87611.78 ± 2.679
CD8+IL9+ (in CD8+)0.14 ± 0.0870.90 ± 0.245
TNFa+ (in CD4+CD25+)52.82 ± 5.01923.29 ± 4.430
IL9+ (in CD4+CD25+)5.06 ± 4.4970.59 ± 0.221
Statistical analysis
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.017
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.300
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.657
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.439
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.449
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.356
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.787
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.121
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.209
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.069
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.402
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.017
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.017
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.026
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.168
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.004
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.013
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.171
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.013
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.013
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.007
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.001
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.002
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.107
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.000
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.022
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.001
  • Healthy Controls vs FTY720 · Wilcoxon (Mann-Whitney) · p = 0.127
SecondaryAbsolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

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.

Time frame:
Baseline, Month 3, Month 6
Reported as:
Mean · absolute cell count
Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
absolute cell countHealthy ControlsVisit 1Visit 2Visit 3
CD3CD4 (Lymphogate)41.19 ± 2.48344.91 ± 1.32113.64 ± 1.71213.9 ± 1.522
CD3CD8 (Lymphogate)23.23 ± 2.17522.91 ± 1.18832.93 ± 1.96732.22 ± 2.169
CD3CD4 (CD3 gate)57.38 ± 2.72262.99 ± 1.44623.26 ± 2.72624 ± 2.788
CD3CD8 (CD3 gate)35.11 ± 2.30531.2 ± 1.35159.52 ± 2.53459.66 ± 2.642
CD4+IFNg+ (in CD4+)7.42 ± 1.9943.61 ± 1.0377.85 ± 2.19713.97 ± 2.972
CD4+IL17+ (in CD4+)1.23 ± 0.1731.27 ± 0.2981.26 ± 0.2242.02 ± 0.342
CD8+IFNg+ (in CD8+)16.45 ± 3.8965.47 ± 2.4635.73 ± 1.96814.7 ± 3.834
CD8+IL17+ (in CD8+)1.71 ± 0.6364.2 ± 0.9239.22 ± 3.1052.23 ± 0.505
IFNg+ (in CD4+CD25+)7.1 ± 1.8961.98 ± 0.4697.07 ± 1.7199.31 ± 1.699
IL17+ (in CD4+CD25+)2.35 ± 0.2642.06 ± 0.411.85 ± 0.312.7 ± 0.451
CD4+IL10+ (in CD4+)1.64 ± 0.330.72 ± 0.1961.51 ± 0.4222.14 ± 0.486
CD4+IL4+ (in CD4+)1.44 ± 2.940.96 ± 0.411.45 ± 0.2942.32 ± 0.43
CD4-CD8-IL4+ (in CD4-CD8-)1.31 ± 0.312.62 ± 1.1251.77 ± 0.2672.64 ± 0.909
CD8+IL10+ (in CD8+)0.52 ± 0.0890.31 ± 0.0960.25 ± 0.1070.67 ± 0.169
IL10+ (in CD4+CD25+)2.57 ± 0.2281.81 ± 0.4642.88 ± 0.4714.03 ± 0.793
IL4+ (in CD4+CD25+)1.88 ± 0.340.5 ± 0.1051.22 ± 0.2241.49 ± 0.316
CD4+TNFa+ (in CD4+)46.86 ± 4.89223.72 ± 4.70729.45 ± 5.68149.96 ± 5.832
CD4+IL9+ (in CD4+)0.22 ± 0.1090.54 ± 0.1630.4 ± 0.0980.47 ± 0.143
CD8+TNFa+ (in CD8+)35 ± 4.87611.78 ± 2.67920.93 ± 5.36141.53 ± 6.18
CD8+IL9+ (in CD8+)0.14 ± 0.0870.9 ± 0.2450.13 ± 0.0610.14 ± 0.068
TNFa+ (in CD4+CD25+)52.82 ± 0.01923.29 ± 4.4330.39 ± 5.39140.4 ± 4.907
IL9+ (in CD4+CD25+)5.06 ± 4.4970.59 ± 0.2210.72 ± 0.2131.3 ± 0.507
SecondaryPercent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

Peripheral blood chemokine cytokine levels measured by flow cytometry in healthy controls at baseline and in RRMS patients between visits during fingolimod treatment

Time frame:
Baseline, Month 3, Month 6
Reported as:
Mean · percent of cell count
Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
percent of cell countHealthy ControlsVisit 1Visit 2Visit 3
CD3 %76.52 ± 1.49471.92 ± 1.13457.61 ± 2.40159.29 ± 2.318
CD19 %11.57 ± 0.01813.72 ± 1.3366.13 ± 0.8475.14 ± 0.427
NK %0.427 ± 1.32810.17 ± 1.16934.48 ± 2.75833.91 ± 2.238
NKT %5.65 ± 0.8555.19 ± 0.76615.55 ± 1.72617.66 ± 1.985
Hi CD16CD56 %1.05 ± 0.1830.93 ± 0.1455.29 ± 1.2966.20 ± 1.423
CD8+IL4+ % (in CD8+)5.64 ± 3.741.87 ± 0.5383.13 ± 0.9641.91 ± 1.225

Adverse events

Collected over 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.. Non-serious events are listed at a 0.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fingolimod 0.5 mg0/66 (0%)3/66 (4.5%)7/66 (10.6%)
All Patients0/66 (0%)3/66 (4.5%)7/66 (10.6%)
Most frequent serious events
Most frequent serious events
EventFingolimod 0.5 mgAll Patients
Sinus bradycardiaCardiac disorders2/662/66
Herpes zosterInfections and infestations1/661/66
Most frequent other events
Most frequent other events
EventFingolimod 0.5 mgAll Patients
InfluenzaInfections and infestations2/662/66
Gamma-glutamyltransferase increasedInvestigations1/661/66
Lymphocyte count decreasedInvestigations1/661/66
White blood cell count decreasedInvestigations1/661/66
HeadacheNervous system disorders1/661/66
Muscle contractions involuntaryNervous system disorders1/661/66

Baseline characteristics

Safety set

Age, Continuous
Age, Continuous(Years)FTY720Healthy VolunteersTotal
Mean35.75 ± 8.2034.73 ± 9.6235.27 ± 8.89
Sex: Female, Male
Sex: Female, Male(Participants)FTY720Healthy VolunteersTotal
Female464086
Male202040
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)FTY720Healthy VolunteersTotal
Turkish6660126
08

Study locations

3 sites
  • Novartis Investigative Site
    Mecidiyeköy, Istanbul 34394, Turkey (Türkiye)
  • Novartis Investigative Site
    Üsküdar, Istanbul 34668, Turkey (Türkiye)
  • Novartis Investigative Site
    Istanbul, 34093, Turkey (Türkiye)
09

References and documents

Study documents

  • Study protocol · Mar 21, 2016
  • Statistical analysis plan · Nov 30, 2017

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Jan 2017, 21 months.

Results were first posted in Sep 2019, 2 years 8 months after primary completion.

Of 31 phase 4 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 66. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2015
First posted
Feb 26, 2015
StartActual
Mar 31, 2015
Primary completionActual
Jan 18, 2017
CompletionActual
Jan 18, 2017
Results first posted
Sep 30, 2019
Last update
Sep 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02373098
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 26, 2015
Start date
Mar 31, 2015
Primary completion
Jan 18, 2017
Completion
Jan 18, 2017
Results posted
Sep 30, 2019
Last update
Sep 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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