Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT01307332
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced MRI Measures of Repair in Alemtuzumab Treated Patients
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients
Status:
COMPLETED
Status Verified Date:
2018-10
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:
iCAMMS-IST
Brief Summary:
There are two parts to this investigator sponsored trial (IST):
1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.
1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.
Detailed Description:
Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; although the majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and an increase in inflammatory bio-assay markers.
Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and sustained lymphocyte depletion and is approved for the treatment of B-cell chronic lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.
There are two parts to this Investigator Sponsored Trial (IST):
1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.
Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and sustained lymphocyte depletion and is approved for the treatment of B-cell chronic lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.
There are two parts to this Investigator Sponsored Trial (IST):
1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
2. To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 142402 | OTHER | Health Canada - NOL | View |