Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS

• Status: Withdrawn
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective study that will explore the mechanisms of efficacy of dimethyl fumarate (DMF) treatment in multiple sclerosis (MS). Investigators will enroll relapsing MS patients who are beginning therapy with DMF into a one-year longitudinal study in which blood and spinal fluid analyses, imaging and clinical studies will be performed to identify and measure changes associated with DMF therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Biogen
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• Diagnosis of Relapsing MS (2010 McDonald Criteria)

• Age greater than or equal to 18.

• Starting treatment with dimethyl fumarate (DMF). Enrolled patients will be either naive to disease modifying therapy (DMT) or will be enrolled after a greater than or equal to 30 days from last dose of prior DMT. If enrolled patients cannot tolerate DMF, the will be replaced by another subject. All subjects will serve as their own control.

Exclusion Criteria:

• Women of Childbearing Potential who are pregnant, breastfeeding, or planning to become pregnant or breastfeed for the duration of the study.

• Chronic diseases that will have effects on the laboratory, clinical and imaging parameters we will study: Insulin-dependent diabetes mellitus, stroke, Alzheimer's disease, auto-immune disorders such as rheumatoid arthritis, lupus, neuromyelitis optica, mixed connective disease, or sjogren's disease.

• Any prior treatment with mitoxantrone or alemtuzumab.

• Those undergoing DMT within the past 12 months with rituximab or daclizumab.

• Patients treated with chronic (monthly) systemic steroids.

• Patients treated with steroids (intravenous, intramuscular, oral or ACTH) with the intent to treat MS within 30 days of the baseline visit.