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Completed

NCT Number: NCT02373098

Fingolimod Effect on Cytokine and Chemokine Levels

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Mecidiyeköy, Istanbul, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod 0.5 mg

Drug

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 outcomes

  1. Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA

    Time frame: Baseline

    Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.

  2. Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients

    Time frame: Baseline

    baseline peripheral blood flow cytometric analysis in study participants

  3. Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline

    Time frame: Baseline

    Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.

Secondary outcomes

  1. Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits

    Time frame: Baseline, month 3, month 6

    Change of serum cytokine and chemokine levels measured by ELISA in RRMS patients treated with fingolimod between visits

  2. Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients

    Time frame: Baseline, Month 3, Month 6

    Peripheral blood chemokine cytokine levels measured by flow cytometry during fingolimod treatment in healthy controls at baseline and in RRMS patients between visits

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

    Time frame: Baseline, Month 3, Month 6

    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.

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

    Time frame: Baseline, Month 3, Month 6

    Peripheral blood chemokine cytokine levels measured by flow cytometry in healthy controls at baseline and in RRMS patients between visits during fingolimod treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2015
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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