Relapsing Remitting Multiple SclerosisPhase 4NCT02373098

Fingolimod Effect on Cytokine and Chemokine Levels

A Phase 4 study testing Fingolimod 0.5 mg in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Relapsing Remitting Multiple Sclerosis
What is being tested?: Fingolimod 0.5 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 3 sitesTurkey (Türkiye)
Study dates: 31 Mar 2015to 18 Jan 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent must be obtained before the beginning of te study
Nonresponder RRMS patients
Last relapse of the patient should be at least 2 months before study entry.
Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry.

Who cannot join

Patients with secondary progressive MS.
Patients with known contraindications for fingolimod treatment.
Other coexistent autoimmune diseases
Pregnant or nursing (lactating) women

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Mecidiyeköy, Istanbul, 34394
Novartis Investigative Site
Üsküdar, Istanbul, 34668

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients

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.

Conditions: Relapsing Remitting Multiple Sclerosis
Being tested: Fingolimod 0.5 mg
Keywords: Fingolimod,cytokine,chemokine,RRMS
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fingolimod 0.5 mgDrug
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.

Study groups in NCT02373098
Study group	Role	What they receive
FTY720	Experimental	Not described Receives: Drug: Fingolimod 0.5 mg
Healthy volunteers	No intervention	Healthy volunteers with no intervention or drug administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
baseline peripheral blood flow cytometric analysis in study participants
Measured: Baseline
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.
Measured: Baseline

Secondary outcomes (4)

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
Measured: Baseline, month 3, month 6
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
Measured: Baseline, Month 3, Month 6
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.
Measured: Baseline, Month 3, Month 6
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
Measured: Baseline, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 201518 Jan 2017

First posted26 Feb 2015 (estimated)
Study start31 Mar 2015
Primary completion18 Jan 2017
Study completion18 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: A 6-month, multicenter, prospective, interventional, single arm, open label study investigating the effects of fingolimod administered according to local label recommendations on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02373098
Sponsor's protocol ID: CFTY720DTR04
Status last verified: Sep 2019
First submitted: 4 Feb 2015
Last updated: 30 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
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Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
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All Relapsing Remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
ClinicalTrials.gov ID: NCT02373098
Acronym / sponsor ID: CFTY720DTR04
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Fingolimod,cytokine,chemokine,RRMS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 31 Mar 2015 (actual)
Primary completion: 18 Jan 2017 (actual)
Study completion: 18 Jan 2017 (actual)
First posted: 26 Feb 2015 (estimated)
Results: Posted 30 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: A 6-month, multicenter, prospective, interventional, single arm, open label study investigating the effects of fingolimod administered according to local label recommendations on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients

Arm	Type	Receives
FTY720	Experimental	Drug: Fingolimod 0.5 mg
Healthy volunteers	No intervention	–Healthy volunteers with no intervention or drug administered.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Written informed consent must be obtained before the beginning of te study
Nonresponder RRMS patients
Last relapse of the patient should be at least 2 months before study entry.
Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry.

Key exclusion criteria (4 listed)

Patients with secondary progressive MS.
Patients with known contraindications for fingolimod treatment.
Other coexistent autoimmune diseases
Pregnant or nursing (lactating) women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fingolimod 0.5 mg66 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.	Drug	FTY720

Primary outcome

Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
Time frame: Baseline
Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
Time frame: Baseline
baseline peripheral blood flow cytometric analysis in study participants
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
Time frame: Baseline
Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.

4 secondary outcomes

Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits
Time frame: Baseline, month 3, month 6
Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Time frame: Baseline, Month 3, Month 6
Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Time frame: Baseline, Month 3, Month 6
Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Time frame: Baseline, Month 3, Month 6

Results and safety

Results posted to the registry on 30 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FTY720	66	54
Healthy Volunteers	60	60

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

Time frame: Baseline. Mean (Standard Error). Unit: pg/ml

Measure	Healthy Controls n = 60	FTY720 n = 66
CCL5 (RANTES)	212.26 (22.48)	404.31 (55.189)
IL-17A	1.15 (0.03)	1.06 (0.029)
CXCL13	110.8 (22.3)	139.68 (46.631)
IL6	0.88 (0.324)	66.53 (65.411)
IL8	3.25 (0.47)	3.57 (0.553)
IL13	0.49 (0.331)	0.3 (0.15)
IL23	1.29 (0.552)	3.04 (0.924)
VLA4	1.17 (0.396)	0.58 (0.201)

Healthy Controls vs FTY720: p = 0.000, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.035, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.911, Wilcoxon (Mann-Whitney)

Population analysed: Intent to treat

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

Time frame: Baseline. Mean (Standard Error). Unit: absolute cell count

Measure	Healthy Controls n = 60	FTY720 n = 66
CD3 abs	2048.14 (263.209)	1610.94 (126.071)
CD19 abs	311.63 (57.592)	327.63 (44.421)
NK abs	281.33 (39.106)	623.57 (394.837)
NKT abs	135.86 (16.627)	104.36 (15.080)
Hi CD16CD56 abs	26.64 (4.399)	20.44 (3.506)
CD4CD25 (CD3 gate)	26.08 (3.159)	27.08 (1.251)
Hi CD4CD25 (CD3 gate)	2.83 (0.383)	3.33 (0.253)

Healthy Controls vs FTY720: p = 0.256, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.587, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.300, Wilcoxon (Mann-Whitney)

Population analysed: Analysis was done in the healthy volunteers and RRMS patients.

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

Time frame: Baseline. Mean (Standard Error). Unit: Percent of cells

Measure	Healthy Controls n = 60	FTY720 n = 66
CD3 %	76.52 (1.494)	71.92 (1.134)
CD19 %	11.57 (1.018)	13.72 (1.336)
NK %	11.04 (1.328)	10.17 (1.169)
NKT %	5.65 (0.855)	5.19 (0.766)
Hi CD16CD56 %	1.05 (0.183)	0.93 (0.145)
CD3CD4 % (Lymphogate)	41.19 (2.483)	44.91 (1.321)
CD3CD8 % (Lymphogate)	23.23 (2.175)	22.91 (1.188)
CD3CD4 % (CD3 gate)	57.38 (2.722)	62.99 (1.446)

Healthy Controls vs FTY720: p = 0.017, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.300, Wilcoxon (Mann-Whitney)
Healthy Controls vs FTY720: p = 0.657, Wilcoxon (Mann-Whitney)

Population analysed: Analysis was done in the healthy volunteers and RRMS patients.

4 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fingolimod 0.5 mg	3 of 66 (4.5%)	7 of 66 (10.6%)	0 of 66
All Patients	3 of 66 (4.5%)	7 of 66 (10.6%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Relapsing Remitting Multiple Sclerosis

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Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod 0.5 mg in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02373098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.