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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02675413
• Date of registration: 11/01/2016
• Prospective Registration: Yes
• Primary sponsor: Washington University School of Medicine
• Public title: Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS
• Scientific title: Mechanisms of Action of Dimethyl Fumarate in Relapsing MS
• Date of first enrolment: April 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02675413
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Laura Piccio, MD
• Affiliation: Washington University School of Medicine

• Name: Anne Cross, MD
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Dimethyl Fumarate

Primary Outcome(s)

Mean differences in Indicators of Oxidative stress (Nitrate, nitrite (um/L), Glutathione (uM), and F2-isoprostanes (pg/ml)) in blood and CSF at baseline and 12 months [Time Frame: 24 months]

Mean differences in markers of axonal damage to assess whether DMF protects against neurodegeneration at baseline and 12 months [Time Frame: 24 months]

Mean differences in MS-relevant cytokines, chemokines and osteopontin to examine the immunologic consequences of DMF therapy during autoimmune CNS inflammation. [Time Frame: 24 months]

Mean differences in the phenotype and activation status of adaptive and innate immune cells in the CSF and peripheral circulation at baseline and 12 months. [Time Frame: 24 months]

Secondary Outcome(s)

Correlation of Biomarkers with Imaging and Clinical Outcome Measures [Time Frame: 24 months]

Secondary ID(s)

201511112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen