Teriflunomide Tecfidera LMCE
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
What it measured
Main measures
Percent change in CGM between teriflunomide and dimethyl fumarate
24 months
LM CE lesions at 24 months
24 months
MRI lesionsCGM atrophy and LM inflammation
24 months
Brain volume loss
Who could take part
MS (type not specified) · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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®)
Papers
Loading reviews and guidelines…
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History
Started
Jun 2018
Main results due
Jul 2019
Finished
Jul 2019
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