Fingolimod Effect on Cytokine and Chemokine Levels

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod 0.5 mg

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul
    • Mecidiyekoy, Istanbul, Turkey, 34394
      • Novartis Investigative Site
    • Uskudar, Istanbul, Turkey, 34668
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FTY720	Drug: Fingolimod 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.
NO_INTERVENTION: Healthy volunteers; Healthy volunteers with no intervention or drug administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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	Baseline, Month 3, Month 6

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2015
• Primary Completion (ACTUAL): January 18, 2017
• Study Completion (ACTUAL): January 18, 2017

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (ESTIMATE): February 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Fingolimod,cytokine,chemokine,RRMS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720DTR04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No