Clinical trial NCT02373098: Fingolimod Effect on Cytokine and Chemokine Levels
Official title: Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Fingolimod,cytokine,chemokine,RRMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
timeFrame: Baseline
measure: Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
timeFrame: Baseline
measure: Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits
timeFrame: Baseline, month 3, month 6
measure: Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
timeFrame: Baseline, Month 3, Month 6
measure: Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
timeFrame: Baseline, Month 3, Month 6
measure: Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
Locations:
city: Mecidiyekoy
country: Turkey
facility: Novartis Investigative Site
state: Istanbul
city: Uskudar
country: Turkey
facility: Novartis Investigative Site
state: Istanbul
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
References: