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A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Active Not RecruitingN/A

Sponsor: Biogen

Conditions: Multiple Sclerosis

Interventions: Diroximel Fumarate, Dimethyl Fumarate, Disease-Modifying Therapies (DMTs)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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/Exclusion criteria may apply

Locations (1)

Cambridge, Massachusetts, United States