Fingolimod Effect on Cytokine and Chemokine Levels

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FTY720

Group Type EXPERIMENTAL

Fingolimod 0.5 mg

Intervention Type DRUG

66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.

Healthy volunteers

Healthy volunteers with no intervention or drug administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fingolimod 0.5 mg

66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No