Fingolimod Effect on Cytokine and Chemokine Levels

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373098
• Other study ID #: CFTY720DTR04
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2015
• Est. completion date: January 18, 2017

Study information

• Verified date: September 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Mecidiyekoy	Istanbul
Turkey	Novartis Investigative Site	Uskudar	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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