NCT05767736

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

An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,500 (estimated)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Diroximel Fumarate	Administered as specified in the treatment arm.
DRUG	Dimethyl Fumarate	Administered as specified in the treatment arm.
DRUG	Disease-Modifying Therapies (DMTs)	Administered as specified in the treatment arm.

Timeline

• Start date: 2024-06-08
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2023-03-14
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study