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

Multiple Sclerosis Clinical Trial

Official title:

An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05767736
• Other study ID #: 272MS403
• Secondary ID: EUPAS45194
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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