Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
Study NCT ID:
NCT04466150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
IMPACT MS
Brief Summary:
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.
Detailed Description:
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients age 18-50 will be treated with ocrelizumab within 90 days of first clinical MS/CIS presentation and re-dosed as maintenance therapy every 6 months for 3 years to see if treatment favorably alters CSF markers of chronic inflammation
Investigators hope data that will provide a foundation for further studies that treating relapsing MS patients at clinical onset (using a B-cell depleting therapy) may improve longer-term outcomes.
Investigators hope data that will provide a foundation for further studies that treating relapsing MS patients at clinical onset (using a B-cell depleting therapy) may improve longer-term outcomes.
Study Oversight
Has Oversight DMC:
True
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?: