Fingolimod Effect on Cytokine and Chemokine Levels

• Status: Completed
• Trial end date: 2017-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

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