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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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The primary aim of this study is to observe any changes in MRI in MS patients who have switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
The primary aim of this study is to observe the effect of switching from daily injections of 20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will exert similar, if not better effect on prevention of thalamic pathology, as compared to GA 20mg/daily. The secondary objective of this study is to investigate the effect of switching from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRMS changing from 20mg to 40mg GA | Relapsing-remitting Multiple Sclerosis patients who are switching from 20mg of glatiramer acetate (GA) to 40mg. The investigator is not influencing this clinical decision, just measuring its impact using MRI metrics. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute and percent change in thalamus pathology as measured by axial and radial diffusivity using diffusion tensor imaging tract-based spatial statistics | The primary endpoint is to explore the effect of GA 40mg x 3/weekly on thalamus pathology, as measured by changes in RD and AD on DTI TBSS in patients with RRMS, as compared to GA 20mg/daily. | 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and percent changes in normal-appearing white and grey matter as measured by fractional anisotropy and mean diffusivity using diffusion tensor imaging tract-based spatial statistics. | The secondary endpoint is to investigate the effect of GA 40mg x 3/weekly on evolution of microstructural changes in NAWM and NAGM, as measured by FA and MD on DTI global and the TBSS (only NAWM) approaches, as compared to GA 20mg/daily. |
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Inclusion Criteria:
Exclusion Criteria:
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One hundred fifty (150) consecutive RRMS patients who are on treatment with GA 20mg/daily for at least 12 months and who switched to GA 40mg x 3/weekly, because of convenience of application, will be recruited in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Zivadinov, MD, PhD | SUNY University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo Neuroimaging Analysis Center | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29571854 | Derived | Zivadinov R, Bergsland N, Hagemeier J, Tavazzi E, Ramasamy DP, Durfee J, Cherneva M, Carl E, Carl J, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of switching from glatiramer acetate 20 mg/daily to glatiramer acetate 40 mg three times a week on gray and white matter pathology in subjects with relapsing multiple sclerosis: A longitudinal DTI study. J Neurol Sci. 2018 Apr 15;387:152-156. doi: 10.1016/j.jns.2018.02.023. Epub 2018 Feb 10. |
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| 1 year after enrollment |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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