Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925049
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-06-21
Brief Title:
A Study Utilising Data From European Union EU National Multiple Sclerosis MS Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis RRMS
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Observational Study Utilising Data From EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 this study is to estimate the incidence of Anti-Natalizumab Antibodies ANAs in the cohort of natalizumab-naïve and other MS monoclonal antibody mAb-naive participants who start receiving natalizumab subcutaneous SC injections The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous IV to natalizumab SC natalizumab-experienced cohort to evaluate serious adverse events SAEs including injection reactions and hypersensitivity reactions by ANA status and to assess the proportion of participants who had MS relapse by ANA status
Detailed Description:
The study will collect data prospectively and retrospectively
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS48753 | OTHER | EU PAS register number | None |