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A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Sponsor: Biogen
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.
Official title: An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10500
Start Date
2024-06-08
Completion Date
2032-12-01
Last Updated
2025-10-16
Healthy Volunteers
No
Conditions
Interventions
Diroximel Fumarate
Administered as specified in the treatment arm.
Dimethyl Fumarate
Administered as specified in the treatment arm.
Disease-Modifying Therapies (DMTs)
Administered as specified in the treatment arm.
Locations (1)
Research Site
Cambridge, Massachusetts, United States