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

Biogen

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Drug: Disease-Modifying Therapies (DMTs); Drug: Dimethyl Fumarate; Drug: Diroximel Fumarate

Study type: Observational

Funder types: Industry

Identifiers

NCT05767736

272MS403

EUPAS1000000285 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 10,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

10,500 participants in 4 patient groups

Vumerity Cohort

Description:

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.

Treatment:

Drug: Diroximel Fumarate

Tecfidera Cohort

Description:

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.

Treatment:

Drug: Dimethyl Fumarate

Vumerity/Tecfidera Switch Cohort

Description:

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.

Treatment:

Drug: Dimethyl Fumarate

Drug: Diroximel Fumarate

Selected Disease Modifying Therapies (DMTs) Treated Cohort

Description:

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.

Treatment:

Drug: Disease-Modifying Therapies (DMTs)