Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.

Official Title
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A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 Exclusion Criteria: Patients with a manifestation of MS other than relapsing remitting MS Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome History or presence of malignancy in the last 5 years Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients Diagnosis of macular edema during Screening Phase Patients with active systemic bacterial, viral or fungal infections Negative for varicella-zoster virus IgG antibodies at Screening Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time History of cardiovascular disorder Women of child-baring potential and inadequate contraception Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod<br> | Drug: Fingolimod<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) |  | 6 Months | 
| Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+) |  | 6 months | 
| Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-) |  | 6 months | 
| Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-) |  | 6 months | 
| Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of B-lymphocytes |  | 6 months | 
| Change from baseline of monocytes |  | 6 months | 
| Change from baseline of Natural Killer cells |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, RRMS, relapsing-remitting, fingolimod, biomarkers