Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Verified date | September 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Mecidiyekoy | Istanbul |
Turkey | Novartis Investigative Site | Uskudar | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Turkey,
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 |
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