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NCT05767736Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
10500 (estimated)
First submitted
2 Mar 2023
Start date
Jun 2024
Primary completion date
Dec 2032
Lead sponsor
Biogen
NCT number
NCT05767736

What you commit to

  • Study type: Observational
  • Planned participants: 10500
  • From Jun 2024 to the primary completion date, Dec 2032
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- None
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Who the study is looking for

  • \- 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
CambridgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.