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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS1000000285 | Registry Identifier | EU PAS Register |
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The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vumerity Cohort | Participants who have been prescribed Vumerity as a newly initiating treatment and not previously treated with Tecfidera are selected and the available data is collected retrospectively. |
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| Tecfidera Cohort | Participants who have been prescribed Tecfidera as a newly initiating treatment and not previously treated with Vumerity are selected and the available data is collected retrospectively. |
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| Vumerity/Tecfidera Switch Cohort | Participants who have been treated with Tecfidera and then switched to Vumerity as per routine medical care are selected and the available data is collected retrospectively. |
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| Selected Disease Modifying Therapies (DMTs) Treated Cohort | Participants who have been prescribed with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) and are not previously treated with Vumerity or Tecfidera are selected and the available data is collected retrospectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diroximel Fumarate | Drug | Administered as specified in the treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts | An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, and other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate). | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort | An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate). |
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Key Inclusion Criteria:
- Participants with MS treated with at least 1 dose of Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), and whose data are captured in the BMSD network will be included in the study.
Key Exclusion Criteria:
- None
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cambridge | Massachusetts | 02142 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| 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 |
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| ID | Term |
|---|---|
| C000722501 | diroximel fumarate |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Dimethyl Fumarate | Drug | Administered as specified in the treatment arm. |
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| Disease-Modifying Therapies (DMTs) | Drug | Administered as specified in the treatment arm. |
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| Up to 10 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |