Teriflunomide Tecfidera LMCE

University at Buffalo120 enrolled

Overview

This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Tecfidera Teriflunomide

Interventions

Dimethyl FumarateDRUG

Individuals with MS treated with dimethyl fumarate (Tecfidera)

TeriflunomideDRUG

Individuals with MS treated with teriflunomide (Aubagio)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with MS according to McDonald criteria * Age 18-65 years * Relapsing disease course * Expanded Disability Status Scale (EDSS) score of ≤ 5.5 * MRI obtained at baseline (medication start date), 12 months, and 24 months * Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label * Clinical information available over the 24 month follow-up * None of the exclusion criteria Exclusion Criteria: * Diagnosis of non-relapsing MS * Use of experimental drug or investigational procedure during the study period * Pregnancy during study period * Severe hepatic impairment * Relapse within 30 days prior to any of the 3 MRIs * Corticosteroid use within 30 days prior to the MRIs * Teriflunomide patients who have used leflunomide * Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone * Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation

Locations (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Outcomes

Primary Outcomes

Percent change in CGM between teriflunomide and dimethyl fumarate

Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate

Time frame: 24 months

LM CE lesions at 24 months

Frequency of leptomeningeal (LM) lesions as measured by presence (number) of LM contrast enhancing (CE) lesions foci on three-dimensional fluid-attenuated-inversion recovery (3D\_FLAIR) MRI performed 10 minutes post-contrast injection between those on teriflunomide and dimethyl fumarate

Time frame: 24 months

CGM atrophy and LM inflammation

Association between the development of CGM atrophy and LM inflammation

Time frame: 24 months

Data from ClinicalTrials.gov

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