Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767736
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-03-02
Brief Title:
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis MS
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS45194 | REGISTRY | EnCePP | None |