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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®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aubagio | Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio). |
| |
| Tecfidera | Individuals diagnosed with multiple sclerosis (MS) who have been treated with dimethyl fumarate (Tecfidera) and matched with the teriflunomide (Aubagio) patients on age, sex, disease duration, and disability level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl Fumarate | Drug | Individuals with MS treated with dimethyl fumarate (Tecfidera) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in CGM between teriflunomide and dimethyl fumarate | Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate | 24 months |
| LM CE lesions at 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 | 24 months |
| CGM atrophy and LM inflammation | Association between the development of CGM atrophy and LM inflammation | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals diagnosed with MS who have used dimethyl fumarate or teriflunomide and had magnetic resonance imaging at baseline (before starting disease modifying therapy (DMT) in question), 12 months after starting DMT, and 24 months after starting DMT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo Neuroimaging Analysis Center | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30870983 | Result | Zivadinov R, Bergsland N, Carl E, Ramasamy DP, Hagemeier J, Dwyer MG, Lizarraga AA, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of Teriflunomide and Dimethyl Fumarate on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective, Observational, Case-Control Pilot Study. J Clin Med. 2019 Mar 12;8(3):344. doi: 10.3390/jcm8030344. |
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No data will be shared with other researchers
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| C527525 | teriflunomide |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Teriflunomide | Drug | Individuals with MS treated with teriflunomide (Aubagio) |
|
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| D009930 |
| Organic Chemicals |