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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05767736
Other study ID # 272MS403
Secondary ID EUPAS45194
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date December 1, 2032

Study information

Verified date May 2024
Source Biogen
Contact US Biogen Clinical Trial Center
Phone 866-633-4636
Email clinicaltrials@biogen.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10500
Est. completion date December 1, 2032
Est. primary completion date December 1, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diroximel Fumarate
Administered as specified in the treatment arm.
Dimethyl Fumarate
Administered as specified in the treatment arm.
Disease-Modifying Therapies (DMTs)
Administered as specified in the treatment arm.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort 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). Up to 10 years
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