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| Name | Class |
|---|---|
| EMD Serono | INDUSTRY |
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The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebif - 1 year MRI cohort | Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months |
| |
| Rebif - 1 year clinical cohort | Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline |
| |
| Rebif - early discontinuation cohort - tolerability | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability |
| |
| Rebif - early discontinuation cohort - adverse events | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events |
| |
| Rebif - early discontinuation cohort - disease activity | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity |
| |
| Tecfidera - 1 year MRI cohort |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| NEDA-2 | Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients. No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical differences between the two treatment groups | Comparison of number of relapses between the two treatment groups. | 12 months |
| Neurological differences between two treatment groups | Comparison of number of new lesions and number of enlarging lesions between the two treatment groups. Unit of measurement is number of each lesion type. |
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Inclusion Criteria:
Exclusion Criteria:
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Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology Associates | Birmingham | Alabama | 35209 | United States | ||
| Colorado Springs Neurological Associates |
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Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months |
|
| Tecfidera - 1 year clinical cohort | Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline |
|
| Tecfidera - early discontinuation cohort - tolerability | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability |
|
| Tecfidera - early discontinuation cohort - adverse events | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events |
|
| Tecfidera - early discontinuation cohort - disease activity | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity |
|
| Tecfidera | Drug |
|
| 12 months |
| Proportion of individuals within each treatment group who discontinued, stratified by reason | Proportion of individuals within each treatment group who discontinued treatment due
| 12 months |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Savannah Neurology Specialists | Savannah | Georgia | 31406 | United States |
| Northshore University | Evanston | Illinois | 60201 | United States |
| OSF Multi-specialty Group d/b/a Illinois Neurological Institute | Peoria | Illinois | 61637 | United States |
| St Elizabeths/ Dragonfly Research | Brighton | Massachusetts | 02135 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | United States |
| Washington university | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Lincoln | Nebraska | 68588 | United States |
| University of Buffalo Clinical and Translational research Center | Buffalo | New York | 14203 | United States |
| Neurological Associates of Long Island | Lake Success | New York | 11042 | United States |
| Onsite Clinical Solutions | Charlotte | North Carolina | 28277 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| Oak Clinic-Multiple Sclerosis | Uniontown | Ohio | 44685 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97228 | United States |
| The university of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| Blacksburg Neurology | Christiansburg | Virginia | 24073 | United States |
| MultiCare Health System | Tacoma | Washington | 98405 | United States |
| Neuroscience Group | Neenah | Wisconsin | 54956 | United States |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 0A9 | Canada |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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