Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310343
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
ADAs to Alemtuzumab
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period
Detailed Description:
Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period
Secondary
1 Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2
2 Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions
3 Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity
4 Relative change in relapses or EDSS score based on alemtuzumab ADA levels
5 Relative change in T2 lesion number or Gd-enhancing lesions and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity
Secondary
1 Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2
2 Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions
3 Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity
4 Relative change in relapses or EDSS score based on alemtuzumab ADA levels
5 Relative change in T2 lesion number or Gd-enhancing lesions and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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