Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial

CompletedPhase 4Relapsing MS2012-000411-91

What was tested

Treatment tested

What it measured

Main measures

  • Status of NK cell maturation, defined as the ratio immature NK cells /total NK cells (percentage), before fingolimod treatment vs. after 12 months of treatment (V4). The maturation status is determined by the expression of certain cell surface markers which can be evaluated by flow cytometry.

Other measures (1)

  • NK cell frequency at all time points (determined by flow cytometry), percentage immature NK cells/total NK cells at all time points, NK cell activation (expression of certain cell surface markers determined by flow cytometry) at all time points, NK cell maturation and activation in relation to clinically detectable therapeutic effect (determined a) by annual relapse rate over study period vs. annu

    Disability progressionRelapsesBlood or spinal fluid markersImmune response

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History

  1. In scope changed from true to false
  1. Started

    Dec 2012

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