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ACTIVE NOT RECRUITING
NCT05767736

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

Sponsor: Biogen

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Research Site

Cambridge, Massachusetts, United States