Tecfidera, Teriflunomide
Conditions
Brief 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®)
Interventions
DRUGDimethyl Fumarate
Individuals with MS treated with dimethyl fumarate (Tecfidera)
DRUGTeriflunomide
Individuals with MS treated with teriflunomide (Aubagio)
Sponsors
University at Buffalo
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in CGM between teriflunomide and dimethyl fumarate | 24 months | Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate |
| LM CE lesions at 24 months | 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 |
| CGM atrophy and LM inflammation | 24 months | Association between the development of CGM atrophy and LM inflammation |
Countries
United States
Outcome results
None listed