CompletedMS (type not specified)NCT03526224

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

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 lesions
  • CGM 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

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Related trials

History

    1. Started

      Jun 2018

    2. Main results due

      Jul 2019

    3. Finished

      Jul 2019

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