NCT02461069

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

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 Sclerosis (DIMAT-MS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Dimethyl fumarate	Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0. At week 1, the dose is increased to 120 mg Tecfidera® p.o. twice daily, split into a morning and an evening dose. At week 2, the daily dose is further increased to 240 mg Tecfidera® p.o. in the morning and 120 mg Tecfidera® p.o. in the evening. Finally at week 3, the dose will be increased to the final daily dose of 240 mg Tecfidera® p.o. in the morning and 240 mg Tecfidera® p.o. in the evening and maintained throughout the study.

Timeline

• Start date: 2015-05-06
• Primary completion: 2018-01-24
• Completion: 2018-05-07
• First posted: 2015-06-03
• Last updated: 2018-10-11

Locations

6 sites across 1 country: Germany