NCT02373098

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

February 4, 2015

Results QC Date

October 4, 2018

Last Update Submit

September 3, 2019

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Fingolimod,cytokine,chemokine,RRMS

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    Baseline

Secondary Outcomes (4)

  • Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits

    Baseline, month 3, month 6

  • Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

    Baseline, Month 3, Month 6

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

    Baseline, Month 3, Month 6

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

    Baseline, Month 3, Month 6

Study Arms (2)

FTY720

EXPERIMENTAL
Drug: Fingolimod 0.5 mg

Healthy volunteers

NO INTERVENTION

Healthy volunteers with no intervention or drug administered.

Interventions

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.

FTY720

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Mecidiyeköy, Istanbul, 34394, Turkey (Türkiye)

Location

Novartis Investigative Site

Üsküdar, Istanbul, 34668, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email.@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 26, 2015

Study Start

March 31, 2015

Primary Completion

January 18, 2017

Study Completion

January 18, 2017

Last Updated

September 30, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-09

Locations

TU(3)