Fingolimod Effect on Cytokine and Chemokine Levels

Study Overview
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Brief Summary
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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.

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

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod 0.5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTY720<br> | Drug: Fingolimod 0.5 mg<br>* 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.<br>|
| No Intervention: Healthy volunteers<br>Healthy volunteers with no intervention or drug administered. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fingolimod,cytokine,chemokine,RRMS