Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05504694
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2022-08-16
Brief Title:
Ofatumumab in AQP4-IgG Seropositive NMOSD
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD an Open-label Single-arm Multicentre Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2022-08
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:
This is an open-label single-arm multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder NMOSD in China
Detailed Description:
Neuromyelitis optica spectrum disorder NMOSD is a rare but severe demyelinating disorder that affects mainly adult patients It is associated with a pathological B cell-mediated humoral immune response against the aquaporin-4 AQP4 water channel Monoclonal antibodies against CD20 have been shown to be effective for prevention of relapses in patients with NMOSD and therefore been recommended as first-line therapy for this disorder Ofatumumab OFA a fully humanized anti-CD20 monoclonal antibody has been approved for multiple sclerosis treatment However prospective multicenter studies are needed to determine the efficacy and safety of ofatumumab in treating NMOSD
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