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

NCT02461069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-10-11

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

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.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Luisa Klotz, Prof. Dr. · University Hospital Muenster

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-06
Primary Completion
2018-01-24
Completion
2018-05-07

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461069 on ClinicalTrials.gov