Clinical Trial: Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 24-week, Multicenter, Exploratory, Two Arm Study to Assess the Effect of Dimethyl Fumarate on Immune-Modulatory Action on T Cells in Patients With Relapsing Remitting Multiple

Brief Summary: This is an exploratory study, which allows analysis of multiple immune parameters derived from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting multiple sclerosis before and during immune-modulatory treatment with dimethyl fumarate in comparison to PBMCs from healthy subjects.

Detailed Summary: The purpose of the trial is to shed more light on the mechanisms of action of dimethyl fumarate in patients with relapsing remitting multiple sclerosis. More specifically the influence of dimethyl fumarate on peripheral immune cells will be addressed to evaluate changes in cytokine production by the distinct T cell subsets and the differentiation capacity of naïve T cells. Furthermore, the impact of dimethyl fumarate treatment on the migratory capacity of T cells as well as the evaluation of changes in the suppressive capacity of regulatory T cells will be evaluated. To put the obtained results into context, response data of dimethyl fumarate-treated patients will be compared with data from healthy subjects.
Sponsor: University Hospital Muenster

Current Primary Outcome:

  • Expression of lymphocyte phenotypic surface markers in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis. [ Time Frame: 0, 8, 16 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Expression of lymphocyte phenotypic surface markers in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis and untreated healthy subjects. [ Time Frame: 0, 8, 16 and 24 weeks after initiation of investigational treatment (week 0) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • T cell effector functions in terms of cytokine production of CD4+ and CD8+ in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis. [ Time Frame: 0, 8, 16 and 24 weeks after initiation of investigational treatment (week 0) ]
  • T cell effector functions in terms of cytokine production of CD4+ and CD8+ in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis and untreated healthy subjects. [ Time Frame: 0, 8, 16 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Differentiation capacity of helper T cell subpopulations (Th1 and Th17 cells) in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Differentiation capacity of helper T cells in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis and untreated healthy subjects. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Migratory capacity of immune cells (percentage of migrated cells) in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Migratory capacity of immune cells (percentage of migrated cells) in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis and untreated healthy subjects. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Suppressive capacity of regulatory T cells in respect to suppression of effector T cell responses in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]
  • Suppressive capacity of regulatory T cells in respect to suppression of effector T cell responses in dimethyl fumarate (Tecfidera®)-treated patients with relapsing-remitting multiple sclerosis and untreated healthy subjects. [ Time Frame: 0 and 24 weeks after initiation of investigational treatment (week 0) ]


Original Secondary Outcome: Same as current

Information By: University Hospital Muenster

Dates:
Date Received: May 27, 2015
Date Started: May 2015
Date Completion: November 2017
Last Updated: December 8, 2015
Last Verified: May 2015