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

NCT05767736 | Active Not Recruiting FDA Drug

• 2 other identifiers: 272MS403EUPAS1000000285
• Study Type: observational
• Target: 10,500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and results in a congenital anomaly/birth defect. The incidence rate of confirmed SAEs, will include but not be limited to malignancies and serious and opportunistic infections among participants with MS who are treated with Vumerity, Tecfidera, and other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate).

  Up to 10 years

Secondary Outcomes (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

Study Arms (4)

Vumerity Cohort

Participants who have been prescribed Vumerity as a newly initiating treatment and not previously treated with Tecfidera are selected and the available data is collected retrospectively.

Drug: Diroximel Fumarate

Tecfidera Cohort

Participants who have been prescribed Tecfidera as a newly initiating treatment and not previously treated with Vumerity are selected and the available data is collected retrospectively.

Drug: Dimethyl Fumarate

Vumerity/Tecfidera Switch Cohort

Participants who have been treated with Tecfidera and then switched to Vumerity as per routine medical care are selected and the available data is collected retrospectively.

Drug: Diroximel Fumarate; Drug: Dimethyl Fumarate

Selected Disease Modifying Therapies (DMTs) Treated Cohort

Participants who have been prescribed with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) and are not previously treated with Vumerity or Tecfidera are selected and the available data is collected retrospectively.

Drug: Disease-Modifying Therapies (DMTs)

Interventions

Diroximel Fumarate DRUG

Administered as specified in the treatment arm.

Also known as: VUMERITY, BIIB098

Vumerity Cohort; Vumerity/Tecfidera Switch Cohort

Dimethyl Fumarate DRUG

Administered as specified in the treatment arm.

Also known as: Tecfidera, DMF, BG00012

Tecfidera Cohort; Vumerity/Tecfidera Switch Cohort

Disease-Modifying Therapies (DMTs) DRUG

Administered as specified in the treatment arm.

Selected Disease Modifying Therapies (DMTs) Treated Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry.

You may qualify if:

• \- 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

diroximel fumarate; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: June 8, 2024
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)