Multiple Sclerosis Clinical Trial
Teriflunomide Tecfidera LMCE
Summary
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®)
Eligibility Criteria
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
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There is 1 Location for this study
Buffalo New York, 14203, United States
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