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

NCT05767736 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10500

Last updated 2025-10-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-08
Primary Completion
2032-12-01
Completion
2032-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767736 on ClinicalTrials.gov