Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
Administered as specified in the treatment arm.
DRUGDimethyl Fumarate
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 10 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort | Up to 10 years | 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). |
Countries
United States
Outcome results
None listed