Teriflunomide Tecfidera LMCE

Completed

Conditions studied: Tecfidera, Teriflunomide

In brief

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®)

Key facts

Study ID

NCT03526224

Run by

University at Buffalo

People needed

120

Starts

2018-06-14

Expected to finish

2019-07-10

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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