Fingolimod Effect on Cytokine and Chemokine Levels

Novartis Pharmaceuticals126 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Relapsing Remitting Multiple Sclerosis

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Novartis Investigative Site

Mecidiyeköy, Istanbul, Turkey (Türkiye)

Novartis Investigative Site

Üsküdar, Istanbul, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: Baseline

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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