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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Biogen
Study ID
NCT05767736
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diroximel Fumarate — DRUG
    Administered as specified in the treatment arm.
  • Dimethyl Fumarate — DRUG
    Administered as specified in the treatment arm.
  • Disease-Modifying Therapies (DMTs) — DRUG
    Administered as specified in the treatment arm.

Study Details

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.

Key Dates

Start date
Jun 8, 2024
Status verified
Oct 2025
Primary completion
Dec 1, 2032
Completion
Dec 1, 2032

Study Design

Enrollment
10,500 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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 [ Time Frame: Up to 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteCambridgeMassachusetts02142-

Find similar trials in Cambridge, MA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Research Site· Cambridge, MA

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