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Fingolimod Effect on Cytokine and Chemokine Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373098
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.


Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Fingolimod 0.5 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Actual Study Start Date : March 31, 2015
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373098


Locations
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Turkey
Novartis Investigative Site
Mecidiyekoy, Istanbul, Turkey, 34394
Novartis Investigative Site
Uskudar, Istanbul, Turkey, 34668
Novartis Investigative Site
Istanbul, Turkey, 34093
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] March 21, 2016
Statistical Analysis Plan  [PDF] November 30, 2017


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02373098    
Other Study ID Numbers: CFTY720DTR04
First Posted: February 26, 2015    Key Record Dates
Results First Posted: September 30, 2019
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Fingolimod,cytokine,chemokine,RRMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs