Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452537
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-05
Brief Title:
Safety and Efficacy of Tocilizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Sponsor:
Tianjin Medical University General Hospital
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
A Randomized Controlled Multicenter Study To Evaluate the Safety and Efficacy of Tocilizumab In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease MOGAD
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TOMATO
Brief Summary:
The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD
Detailed Description:
Myelin oligodendrocyte glycoprotein antibody-associated disease MOGAD is a rare autoimmune disease of the central nervous system which can cause optic neuritis myelitis brainstem encephalitis or encephalitis The specific autoantibody against myelin oligodendrocyte glycoprotein antibody MOG-IgG has been indicated to contribute to the pathogenesis of the disease Data from several cohorts suggests that around 50 of adult patients with MOG-IgG may relapse within the first two years of the disease with most of relapses occurring early after disease onset Few randomized controlled trials have ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event There is no drug approved for MOGAD by FDA IL-6 is a pro-inflammatory cytokine which can promotes B cell activation blood-brain barrier dysfunction leukocyte migration and the production of autoantibodies Tocilizumab ACTEMRA a humanized monoclonal antibody against the IL-6 receptor has shown beneficial clinical effects and reduction of the risk of relapses in some patients with MOGAD However the efficacy of tocilizumab in MOGAD warrants further clinical trials
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