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The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | delayed release capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation | 6 and 12 months | |
| Estimated CD4+ count change from baseline following Tecfidera initiation | 6 and 12 months | |
| Estimated CD8+ count change from baseline following Tecfidera initiation | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation | 6 and 12 months | |
| Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+) | 6 and 12 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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This study will be conducted in patients with relapsing forms of multiple sclerosis (MS) who initiated Tecfidera treatment for the first time (treatment naïve) under routine clinical care. For inclusion in the study, patients' charts must have a baseline measurement for absolute lymphocyte count (ALC) and absolute CD4+ or CD8+ count within 6 months prior to Tecfidera initiation, and at least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera treatment for at least 6 months. For patients who discontinue Tecfidera, data will be collected for up to 6 months following Tecfidera discontinuation.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Homewood | Alabama | 35209 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009894 | Opportunistic Infections |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation | 6 and 12 months |
| Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation | 6 and 12 months |
| Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation | 6 and 12 months |
| Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation | 6 and 12 months |
| Time to pre-determined lymphocyte counts following Tecfidera initiation | Up to 12 months |
| Potential predictors of low lymphocyte counts following Tecfidera initiation | 6 and 12 months |
| Newport Beach |
| California |
| 92663 |
| United States |
| Research Site | Atlanta | Georgia | 30309 | United States |
| Research Site | Buffalo | New York | 14203 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | Philadelphia | Pennsylvania | 19125 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| Research Site | Seattle | Washington | 98104 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007239 | Infections |
| D009930 |
| Organic Chemicals |