Fingolimod Effect on Cytokine and Chemokine Levels

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Fingolimod 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02373098

CFTY720DTR04

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

FTY720

Experimental group

Treatment:

Drug: Fingolimod 0.5 mg

Healthy volunteers

No Intervention group

Description:

Healthy volunteers with no intervention or drug administered.