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

Sponsor
Biogen (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05767736
Collaborator
(none)
10,500
Enrollment
56
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diroximel Fumarate
  • Drug: Dimethyl Fumarate
  • Drug: Disease-Modifying Therapies (DMTs)

Study Design

Study Type:
Observational
Anticipated Enrollment :
10500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
Anticipated Study Start Date :
Jun 4, 2023
Anticipated Primary Completion Date :
Feb 2, 2028
Anticipated Study Completion Date :
Feb 2, 2028

Arms and Interventions

Arm Intervention/Treatment
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
Administered as specified in the treatment arm.
Other Names:
  • VUMERITY
  • BIIB098

    		•
    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
    Administered as specified in the treatment arm.
    Other Names:
  • Tecfidera
  • DMF
  • BG00012

    		•
    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
    Administered as specified in the treatment arm.
    Other Names:
  • VUMERITY
  • BIIB098

    • Drug: Dimethyl Fumarate
    Administered as specified in the treatment arm.
    Other Names:
  • Tecfidera
  • DMF
  • BG00012

    		•
    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)
    Administered as specified in the treatment arm.

    Outcome Measures

    Primary Outcome Measures

    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 [Up to 10 years]

      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).

    Secondary Outcome Measures

    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]

      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, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT05767736
    Other Study ID Numbers:
    • 272MS403
    • EUPAS45194
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Dimethyl Fumarate

    Study Results

    No Results Posted as of Mar 14, 2023