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Fingolimod Effect on Cytokine and Chemokine Levels

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Fingolimod 0.5 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Fingolimod,cytokine,chemokine,RRMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FTY720

Healthy volunteers

Arm Description

Healthy volunteers with no intervention or drug administered.

Outcomes

Primary Outcome Measures

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 Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
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
Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.

Secondary Outcome Measures

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
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
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.
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

Full Information

First Posted
February 4, 2015
Last Updated
September 3, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02373098
Brief Title
Fingolimod Effect on Cytokine and Chemokine Levels
Official Title
Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
January 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Fingolimod,cytokine,chemokine,RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTY720
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
No Intervention
Arm Description
Healthy volunteers with no intervention or drug administered.
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
Description
Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.
Time Frame
Baseline
Title
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
Description
baseline peripheral blood flow cytometric analysis in study participants
Time Frame
Baseline
Title
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
Description
Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits
Description
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
Title
Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Description
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
Title
Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Description
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
Title
Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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: Patients with secondary progressive MS. Patients with known contraindications for fingolimod treatment. Other coexistent autoimmune diseases Pregnant or nursing (lactating) women
Facility Information:
Facility Name
Novartis Investigative Site
City
Mecidiyekoy
State/Province
Istanbul
ZIP/Postal Code
34394
Country
Turkey
Facility Name
Novartis Investigative Site
City
Uskudar
State/Province
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

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Fingolimod Effect on Cytokine and Chemokine Levels

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