Stopped earlyPhase 4Relapsing MS2016-001515-20

What it found

Stopped early

The trial ended early for another reason (see below).

What was tested

Treatment tested

What it measured

Main measures

  • To evaluate the correlation between hange of the subpopulations of effector pro-inflammatory and anti-inflammatory T cells (% Th1 +% TC1 +% Th17 +% Tc17-% Th2) characterized by flow cytometry analysis, at baseline and during the early stages of treatment with teriflunomide to clinical and radiological response in one year of therapy.

Other measures (1)

  • To Assess the change from baseline in the subgroup of effector pro-inflammatory and anti-inflammatory T cells (% Th1 +% TC1 +% Th17 +% Tc17-% Th2) analyzed by flow cytometry, during treatment with teriflunomide to characterize which phenotype of immune response is primarily involved in the mechanism of action of the drug.

    Immune response

Who could take part

Relapsing MS

Inclusion: Patients of male or female aged> 18 years, with relapsing remitting multiple sclerosis diagnosed according to the McDonald criteria 2010. Only patients candidates to treatment with teriflunomide will be enrolled Exclusion: <18 years of age; > 55 years of age.

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

About this trial

In the sponsor's words

The immunological profile of patients with multiple sclerosis is defined by the mutual balance of subpopulations of effector T cells, expressed as a sum of subpopulations of effector pro-inflammatory T cells and anti-inflammatory T cells (% Th1 +% TC1 +% Th17 +% Tc17-% Th2) .

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History

    1. Started

      Feb 2018

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