MSFrontier

Biobank

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
CompletedPhase 4Relapsing MSNCT013101662010-022066-28

What it found

No result found

We found no results in the registry or in papers.

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)

    6 Months

    Immune response

  • Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)

    6 months

    Immune response

  • Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)

    6 months

    Thinking and memoryImmune response

  • Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)

    6 months

    Thinking and memoryImmune response

  • Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)

    6 months

    Thinking and memoryImmune response

  • The primary endpoints are the reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of effector memory T cells (CCR7- CD45RA-) in peripheral venous blood at month 6 versus baseline.

    Thinking and memoryImmune response

Other measures (4)

  • Change from baseline of B-lymphocytes

    6 months

    Immune response

  • Change from baseline of monocytes

    6 months

  • Change from baseline of Natural Killer cells

    6 months

  • To investigate changes from baseline in B Lymphocytes, monocytes and NK cells after

    Immune response

Who could take part

Relapsing MS · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        Feb 2011

      2. Main results due

        Jul 2012

      3. Finished

        Jul 2012

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