Fingolimod Effect on Cytokine and Chemokine Levels

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02373098
• Date of registration: 04/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Fingolimod Effect on Cytokine and Chemokine Levels
• Scientific title: Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
• Date of first enrolment: March 31, 2015
• Target sample size: 126
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02373098
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Turkey

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: Fingolimod 0.5 mg

Primary Outcome(s)

Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA [Time Frame: Baseline]

Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline [Time Frame: Baseline]

Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients [Time Frame: Baseline]

Secondary Outcome(s)

Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients [Time Frame: Baseline, Month 3, Month 6]

Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits [Time Frame: Baseline, month 3, month 6]

Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients [Time Frame: Baseline, Month 3, Month 6]

Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients [Time Frame: Baseline, Month 3, Month 6]

Secondary ID(s)

CFTY720DTR04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02373098