A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
What it found
No result yet.
What was tested
Treatment tested
- Diroximel fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Disease-Modifying Therapies (DMTs)
What it measured
Main measures
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
Immune responseSafety
Other measures (1)
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
Immune responseSafety
Who could take part
MS (type not specified) · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Jun 2024
Main results due
Dec 2032
Finished
Dec 2032
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