Fingolimod Effect on Cytokine and Chemokine Levels

Phase 4

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: Fingolimod 0.5 mg

• Registration Number: NCT02373098
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Study Start: 2015-03-31
• Primary Completion: 2017-01-18
• Study Completion: 2017-01-18
• Results First Submitted: 2018-10-04
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-03
• Last Update Submitted: 2019-09-03
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FTY720	Fingolimod 0.5 mg	-

Primary Outcome Measures

Name	Time	Method
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients	Baseline	baseline peripheral blood flow cytometric analysis in study participants
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA	Baseline	Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline	Baseline	Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.

Secondary Outcome Measures

Name	Time	Method
Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits	Baseline, month 3, month 6	Change of serum cytokine and chemokine levels measured by ELISA in RRMS patients treated with fingolimod between visits
Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	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
Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	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.
Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Istanbul, Turkey